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Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
NDH
Nail, Fixation, Bone, Metallic
2
Product Code
HRY
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
2
Product Code
HRZ
Prosthesis, Knee, Hinged (Metal-Metal)
3
Product Code
HSA
Prosthesis, Knee, Hemi-, Femoral
3
Product Code
HSB
Rod, Fixation, Intramedullary And Accessories
2
Product Code
NDI
Staple, Fixation, Bone, Metallic
2
Product Code
HRS
Plate, Fixation, Bone
2
Product Code
HSD
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
2
Product Code
HSH
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
2
Product Code
HSN
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
2
Product Code
HSX
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
2
Product Code
HTG
Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
2
Product Code
HTN
Washer, Bolt Nut
2
Product Code
HTY
Pin, Fixation, Smooth
2
Product Code
HWC
Screw, Fixation, Bone
2
Product Code
HXA
Prosthesis, Tendon, Passive
2
Product Code
JDB
Prosthesis, Elbow, Semi-Constrained, Cemented
2
Product Code
JDC
Prosthesis, Elbow, Constrained, Cemented
2
Product Code
JDD
Prosthesis, Upper Femoral
2
Product Code
JDG
Prosthesis, Hip, Femoral Component, Cemented, Metal
2
Product Code
JDH
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
3
Product Code
JDI
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
2
Product Code
JDL
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
3
Product Code
JDN
Implant, Fixation Device, Spinal
2
Product Code
JDO
Device, Fixation, Proximal Femoral, Implant
2
Product Code
JDP
Condylar Plate Fixation Implant
2
Product Code
JDQ
Cerclage, Fixation
2
Product Code
JDR
Staple, Fixation, Bone
2
Product Code
JDS
Nail, Fixation, Bone
2
Product Code
JDT
Cap, Bone
1
Product Code
JDW
Pin, Fixation, Threaded
2
Product Code
K
24
1357
XT3 System
2
Cleared 510(K)
K
22
3112
MAVERICK Mini External Fixation System
2
Cleared 510(K)
K
21
3874
MAVERICK External Fixation System
2
Cleared 510(K)
K
21
1508
Steinmann Pins and Kirschner Wires
2
Cleared 510(K)
K
21
0784
Extended HA Half Pins
2
Cleared 510(K)
K
20
0933
Syntec Non-Sterile Steinmann Pins System
2
Cleared 510(K)
K
19
1803
Orthopedic Fixation Pin
2
Cleared 510(K)
K
19
2768
Temporary Fixation Pins
2
Cleared 510(K)
K
18
2171
SMV Scientific K-Wire and Pins
2
Cleared 510(K)
K
16
3487
Ultima HA Coated Half Pins and Wire
2
Cleared 510(K)
K
15
0661
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
2
Cleared 510(K)
K
13
2820
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
2
Cleared 510(K)
K
14
0875
OPTOSSOL COMPRESSION DEVICE SYSTEM
2
Cleared 510(K)
K
13
1459
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
2
Cleared 510(K)
K
13
0298
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
2
Cleared 510(K)
K
12
0871
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
2
Cleared 510(K)
K
10
3001
ROCKWOOD CLAVICLE PINS
2
Cleared 510(K)
K
10
2777
TWISTCUT ENDOSORB SCREWS
2
Cleared 510(K)
K
10
0414
PROTOE ENDOSORB SMALL HAMMER TOE PIN
2
Cleared 510(K)
K
08
3144
ACUMED CLAVICLE SCREW SYSTEM
2
Cleared 510(K)
K
07
2710
NEXFIX COMPRESSION PIN
2
Cleared 510(K)
K
07
1540
SBI TITANIUM THREADED PIN
2
Cleared 510(K)
K
06
1599
PIN SCREW
2
Cleared 510(K)
K
06
1493
APEX PINS
2
Cleared 510(K)
K
06
1498
ALLOFIX ANCHOR, 5.0 MM ANCHOR
2
Cleared 510(K)
K
05
3513
T-PIN
2
Cleared 510(K)
K
05
1740
TAPERED COMPRESSION PIN
2
Cleared 510(K)
K
04
0765
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
2
Cleared 510(K)
K
03
3289
MODIFICATION TO JET-X HA COATED HALF PINS
2
Cleared 510(K)
K
03
2532
TARAS THREADED FIXATION PIN
2
Cleared 510(K)
K
03
1154
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
2
Cleared 510(K)
K
03
0336
KMEDIC EXTERNAL FIXATION DEVICES
2
Cleared 510(K)
K
02
3921
JET-X HA COATED HALF PINS
2
Cleared 510(K)
K
02
3134
JET-X TIN COATED HALF PINS
2
Cleared 510(K)
K
02
1182
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
2
Cleared 510(K)
K
02
0097
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
2
Cleared 510(K)
K
01
2270
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
2
Cleared 510(K)
K
01
1875
MODIFICATION TO THE TAC' PIN
2
Cleared 510(K)
K
01
1319
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
2
Cleared 510(K)
K
01
1137
RESORBABLE HAMMERTOE PIN
2
Cleared 510(K)
K
01
1136
APEX FIXATION PINS
2
Cleared 510(K)
K
00
2605
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
2
Cleared 510(K)
K
00
3294
BIOMET LATERAL TROCH PLATE
2
Cleared 510(K)
K
00
3131
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
2
Cleared 510(K)
K
00
1720
SYNTHES SACRAL BAR SYSTEM
2
Cleared 510(K)
K
00
1886
APEX FIXATION PINS
2
Cleared 510(K)
K
00
1228
EXTERNAL FIXATION ANCHOR PIN
2
Cleared 510(K)
K
99
4143
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
2
Cleared 510(K)
K
99
3910
TAC' PIN
2
Cleared 510(K)
K
99
2970
DIGIT WIDGET
2
Cleared 510(K)
K
99
1649
DEPUY ROCKWOOD CLAVICLE PIN
2
Cleared 510(K)
K
99
0353
STAINLESS STEEL FIXATION PINS
2
Cleared 510(K)
K
98
3757
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01
2
Cleared 510(K)
K
98
2931
THREADED FIXATION PIN
2
Cleared 510(K)
K
98
2068
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
2
Cleared 510(K)
K
98
1716
EXTERNAL FIXATION
2
Cleared 510(K)
K
98
0788
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
2
Cleared 510(K)
K
97
4186
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
2
Cleared 510(K)
K
97
4911
EXTERNAL FIXATOR
2
Cleared 510(K)
K
97
0751
HEIDELBERG EXTERNAL FIXATOR
2
Cleared 510(K)
K
97
0713
COMPASS UNIVERSAL HINGE
2
Cleared 510(K)
K
97
0097
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
2
Cleared 510(K)
K
96
4893
HANSSON PIN SYSTEM
2
Cleared 510(K)
K
96
3973
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
2
Cleared 510(K)
K
96
3433
THREADED FIXATION PIN
2
Cleared 510(K)
K
96
1920
CROSS PIN
2
Cleared 510(K)
K
95
5848
ORTHOFIX MODULSYSTEM
2
Cleared 510(K)
K
96
0023
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
2
Cleared 510(K)
K
95
5780
RIGIDYNE A EXTERNAL FIXATION SYSTEM
2
Cleared 510(K)
K
95
4630
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM
2
Cleared 510(K)
K
95
0009
POWERGRIP(TM) COMPRESSION FIXATION DEVICE
2
Cleared 510(K)
K
95
2640
CANNULATED PLUS HIP SCREW
2
Cleared 510(K)
K
94
6228
CROSS PIN SCREW SYSTEM
2
Cleared 510(K)
K
94
5670
KIRSCHNER (K-WIRE), STEINMAN PINS
2
Cleared 510(K)
K
93
2349
ORTHOPEDIC THREADED PIN FIXATION
2
Cleared 510(K)
K
90
5347
HAGIE PIN
2
Cleared 510(K)
K
90
5336
STEINMAN PIN, THREADED
2
Cleared 510(K)
K
90
5344
KNOWLES PIN
2
Cleared 510(K)
K
90
3261
RUSH PIN
2
Cleared 510(K)
K
90
3266
STEINMAN PIN, THREAD
2
Cleared 510(K)
K
89
5173
SKELETAL FIXATION PIN
2
Cleared 510(K)
K
88
1511
FIXATOR PIN (EXTERNAL)
2
Cleared 510(K)
K
87
5013
ACE PERCUTANEOUS 3MM HALF-PINS
2
Cleared 510(K)
K
87
5022
ACE/FISHER PERCUTANEOUS TRANSFIXING PINS
2
Cleared 510(K)
K
87
5012
ACE/FISCHER PERCUTANEOUS HALF PINS
2
Cleared 510(K)
K
87
5021
ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM
2
Cleared 510(K)
K
86
1766
HOWMEDICA HOFFMANN FIXATION PIN SYSTEM
2
Cleared 510(K)
K
84
2293
PARTIALLY THREADED BONE FIX. PIN
2
Cleared 510(K)
K
84
0286
BROOKER EXTERNAL FIXATION FRAME
2
Cleared 510(K)
K
83
3907
CREIGHTON FIXATOR
2
Cleared 510(K)
K
78
1251
THREADED PIN, SELF DRILLING
2
Cleared 510(K)
K
76
0454
GOUFFON PIN, ADJUSTABLE
2
Cleared 510(K)
JEC
Component, Traction, Invasive
2
Product Code
JWH
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
2
Product Code
JWI
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
2
Product Code
JWJ
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
2
Product Code
KIG
Prosthesis, Wrist, Constrained, Polymer
2
Product Code
KMB
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
2
Product Code
KMC
Prosthesis, Hip, Semi-Constrained, Composite/Metal
2
Product Code
KMD
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite
2
Product Code
KRN
Metal Cemented Constrained Femorotibial Knee Prosthesis
3
Product Code
KRO
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
2
Product Code
KRP
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
3
Product Code
KRQ
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
2
Product Code
KRR
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
2
Product Code
KRS
Prosthesis, Knee, Hemi-, Femoral (Uncemented)
3
Product Code
KTT
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
2
Product Code
KTW
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
2
Product Code
KTX
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
2
Product Code
KWA
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
3
Product Code
KWB
Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
3
Product Code
KWD
Prosthesis, Toe, Hemi-, Phalangeal
2
Product Code
KWE
Prosthesis, Finger, Constrained, Metal, Uncemented
3
Product Code
KWF
Prosthesis, Finger, Polymer
2
Product Code
KWG
Prosthesis, Finger, Constrained, Metal/Polymer
3
Product Code
KWH
Prosthesis, Toe, Constrained, Polymer
2
Product Code
KWI
Prosthesis, Elbow, Hemi-, Radial, Polymer
2
Product Code
KWJ
Prosthesis, Elbow, Hemi-, Humeral, Metal
3
Product Code
KWK
Appliance, Nail/Blade/Plate Combination, Single Component
2
Product Code
KWL
Prosthesis, Hip, Hemi-, Femoral, Metal
2
Product Code
KWM
Prosthesis, Wrist, Semi-Constrained
2
Product Code
KWN
Prosthesis, Wrist, Carpal Lunate
2
Product Code
KWO
Prosthesis, Wrist, Carpal Scaphoid
2
Product Code
KWP
Appliance, Fixation, Spinal Interlaminal
2
Product Code
KWQ
Appliance, Fixation, Spinal Intervertebral Body
2
Product Code
KWR
Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
3
Product Code
KWS
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
2
Product Code
KWT
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
2
Product Code
KWY
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
2
Product Code
KWZ
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
2
Product Code
KXA
Prosthesis, Hip, Femoral, Resurfacing
2
Product Code
KXB
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer
3
Product Code
KXC
Prosthesis, Ankle, Cemented, Non-Constrained
3
Product Code
KXD
Prosthesis, Hip, Constrained, Metal
3
Product Code
KXE
Prosthesis, Wrist, Hemi-, Ulnar
2
Product Code
KYI
Prosthesis, Wrist, Carpal Trapezium
2
Product Code
KYJ
Prosthesis, Finger, Constrained, Polymer
2
Product Code
KYK
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
2
Product Code
KYM
Metallic Cemented Glenoid Hemi-Shoulder Prosthesis
3
Product Code
KYN
Prosthesis, Wrist, Constrained, Metal
3
Product Code
LBC
Prosthesis, Finger, Constrained, Metal, Cemented
3
Product Code
LGE
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
2
Product Code
LOD
Bone Cement
2
Product Code
LPH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
2
Product Code
LRN
Wire, Surgical
2
Product Code
LTO
Spacer, Cement
3
Product Code
LWJ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
2
Product Code
LXT
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
2
Product Code
LYP
Accessories, Fixation, Spinal Interlaminal
2
Product Code
LYT
Fixation Accessory
2
Product Code
LZO
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
2
Product Code
LZY
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
2
Product Code
MAI
Fastener, Fixation, Biodegradable, Soft Tissue
2
Product Code
MAX
Intervertebral Fusion Device With Bone Graft, Lumbar
2
Product Code
MAY
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
2
Product Code
MBB
Bone Cement, Antibiotic
2
Product Code
MBF
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
2
Product Code
MBH
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
2
Product Code
MBI
Fastener, Fixation, Nondegradable, Soft Tissue
2
Product Code
MBL
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
2
Product Code
MBP
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
2
Product Code
MBV
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
2
Product Code
MEH
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
2
Product Code
MJW
Prosthesis, Subtalar, Plug, Polymer
2
Product Code
MNH
Orthosis, Spondylolisthesis Spinal Fixation
2
Product Code
MNI
Orthosis, Spinal Pedicle Fixation
2
Product Code
MNU
Staple, Absorbable
2
Product Code
MQP
Spinal Vertebral Body Replacement Device
2
Product Code
MQV
Filler, Bone Void, Calcium Compound
2
Product Code
MRY
Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component
2
Product Code
NDD
Cerclage, Fixation, Metallic
2
Product Code
NDE
Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible
2
Product Code
NDF
Plate, Fixation, Bone, Non-Spinal, Metallic
2
Product Code
NDG
Washer, Bolt, Nut, Non-Spinal, Metallic
2
Product Code
NDJ
Screw, Fixation, Bone, Non-Spinal, Metallic
2
Product Code
NDK
System, External Fixator (With Metallic Invasive Components)
2
Product Code
NDL
Pin, Fixation, Smooth, Metallic
2
Product Code
NDM
Pin, Fixation, Threaded, Metallic
2
Product Code
NDN
Cement, Bone, Vertebroplasty
2
Product Code
NJA
Accessory, System, External Fixator, Containing Antimicrobial Agent
2
Product Code
NJD
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
2
Product Code
NKB
Thoracolumbosacral Pedicle Screw System
2
Product Code
NKG
Posterior Cervical Screw System
2
Product Code
NOV
Anchor, Suture, Bone Fixation, Metallic
2
Product Code
NPJ
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
2
Product Code
NQP
Posterior Metal/Polymer Spinal System, Fusion
2
Product Code
NQW
Orthosis, Spine, Plate, Laminoplasty, Metal
2
Product Code
NUD
Vertebroplasty Compound, Calcium Based
2
Product Code
NVC
Bone, Heterograft
3
Product Code
NWN
Laparoscopic Bone Anchor Urethropexy Instrument Kit
2
Product Code
OBL
Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
2
Product Code
OBM
Cement, Bone, Vertebroplasty, Pre-Formed, Modular
2
Product Code
OBT
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
2
Product Code
OCG
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
3
Product Code
ODP
Intervertebral Fusion Device With Bone Graft, Cervical
2
Product Code
OIS
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
2
Product Code
OIY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
2
Product Code
OJB
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
2
Product Code
OJM
Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
2
Product Code
OOG
Knee Arthroplasty Implantation System
2
Product Code
OOL
Electronic Depth Gauge
2
Product Code
OQB
Intervertebral Body Graft Containment Device
2
Product Code
OQG
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
2
Product Code
OQH
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
2
Product Code
OQI
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
2
Product Code
OSH
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
2
Product Code
OSN
Software For Diagnosis/Treatment
2
Product Code
OUR
Sacroiliac Joint Fixation
2
Product Code
OVD
Intervertebral Fusion Device With Integrated Fixation, Lumbar
2
Product Code
OVE
Intervertebral Fusion Device With Integrated Fixation, Cervical
2
Product Code
OVZ
Pin, Fixation, Resorbable, Hard Tissue
2
Product Code
OWI
Bone Fixation Cerclage, Sublaminar
2
Product Code
OYK
Ankle Arthroplasty Implantation System
2
Product Code
OZI
Internal Hinged Elbow Fixator
2
Product Code
PAO
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
2
Product Code
PBF
Orthopaedic Surgical Planning And Instrument Guides
2
Product Code
PBI
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
2
Product Code
PEK
Spinous Process Plate
2
Product Code
PHM
Intervertebral Fusion Device With Bone Graft, Thoracic
2
Product Code
PHQ
Anterior Staple As Supplemental Fixation For Fusion
2
Product Code
PHX
Shoulder Prosthesis, Reverse Configuration
2
Product Code
PKC
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
2
Product Code
PLF
Bone Wedge
2
Product Code
PLR
Spinal Vertebral Body Replacement Device - Cervical
2
Product Code
PLW
Acetabular Cup Orientation System
2
Product Code
PML
Bone Cement, Posterior Screw Augmentation
2
Product Code
PPQ
Transtibial Anterior Cruciate Ligament Kit
2
Product Code
QHQ
Total Shoulder Arthroplasty System
2
Product Code
PQC
Pedicle Screw Placement Guide
2
Product Code
QAC
Screw Sleeve Bone Fixation Device
2
Product Code
QAD
Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
2
Product Code
QFP
Intraoperative Orthopedic Strain Sensor
2
Product Code
QHE
Shoulder Arthroplasty Implantation System
2
Product Code
QNI
Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
2
Product Code
QPP
Implantable Post-Surgical Kinematic Measurement Knee Device
2
Product Code
QPQ
Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
2
Product Code
JDJ
Mesh, Surgical, Acetabular, Hip, Prosthesis
2
Product Code
JDK
Prosthesis, Hip, Cement Restrictor
2
Product Code
LZN
Cement Obturator
2
Product Code
OLC
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
2
Product Code
QSD
Posterior Cervical Screw Placement Guide
2
Product Code
QSR
Sacroiliac Screw Placement Guide
2
Product Code
QVI
Screw Sleeve Bone Fixation Device, Spine
2
Product Code
QUW
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
2
Product Code
QWJ
Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
2
Product Code
SAI
Ankle Fusion Cage
2
Product Code
SCY
Sacroiliac Joint Guidewire Placement Device
2
Product Code
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 May 2025 at 11:05 pm
OR
/
subpart-d—prosthetic-devices
/
JDW
/
K103001
View Source
ROCKWOOD CLAVICLE PINS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103001
510(k) Type
Traditional
Applicant
DEPUY ORTHOPAEDICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/17/2011
Days to Decision
134 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
NDH
Nail, Fixation, Bone, Metallic
HRY
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
HRZ
Prosthesis, Knee, Hinged (Metal-Metal)
HSA
Prosthesis, Knee, Hemi-, Femoral
HSB
Rod, Fixation, Intramedullary And Accessories
NDI
Staple, Fixation, Bone, Metallic
HRS
Plate, Fixation, Bone
HSD
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
HSH
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
HSN
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
HSX
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
HTG
Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
HTN
Washer, Bolt Nut
HTY
Pin, Fixation, Smooth
HWC
Screw, Fixation, Bone
HXA
Prosthesis, Tendon, Passive
JDB
Prosthesis, Elbow, Semi-Constrained, Cemented
JDC
Prosthesis, Elbow, Constrained, Cemented
JDD
Prosthesis, Upper Femoral
JDG
Prosthesis, Hip, Femoral Component, Cemented, Metal
JDH
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
JDI
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
JDL
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
JDN
Implant, Fixation Device, Spinal
JDO
Device, Fixation, Proximal Femoral, Implant
JDP
Condylar Plate Fixation Implant
JDQ
Cerclage, Fixation
JDR
Staple, Fixation, Bone
JDS
Nail, Fixation, Bone
JDT
Cap, Bone
JDW
Pin, Fixation, Threaded
K
24
1357
XT3 System
K
22
3112
MAVERICK Mini External Fixation System
K
21
3874
MAVERICK External Fixation System
K
21
1508
Steinmann Pins and Kirschner Wires
K
21
0784
Extended HA Half Pins
K
20
0933
Syntec Non-Sterile Steinmann Pins System
K
19
1803
Orthopedic Fixation Pin
K
19
2768
Temporary Fixation Pins
K
18
2171
SMV Scientific K-Wire and Pins
K
16
3487
Ultima HA Coated Half Pins and Wire
K
15
0661
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
K
13
2820
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
K
14
0875
OPTOSSOL COMPRESSION DEVICE SYSTEM
K
13
1459
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
K
13
0298
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
K
12
0871
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K
10
3001
ROCKWOOD CLAVICLE PINS
K
10
2777
TWISTCUT ENDOSORB SCREWS
K
10
0414
PROTOE ENDOSORB SMALL HAMMER TOE PIN
K
08
3144
ACUMED CLAVICLE SCREW SYSTEM
K
07
2710
NEXFIX COMPRESSION PIN
K
07
1540
SBI TITANIUM THREADED PIN
K
06
1599
PIN SCREW
K
06
1493
APEX PINS
K
06
1498
ALLOFIX ANCHOR, 5.0 MM ANCHOR
K
05
3513
T-PIN
K
05
1740
TAPERED COMPRESSION PIN
K
04
0765
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
K
03
3289
MODIFICATION TO JET-X HA COATED HALF PINS
K
03
2532
TARAS THREADED FIXATION PIN
K
03
1154
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
K
03
0336
KMEDIC EXTERNAL FIXATION DEVICES
K
02
3921
JET-X HA COATED HALF PINS
K
02
3134
JET-X TIN COATED HALF PINS
K
02
1182
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
K
02
0097
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
K
01
2270
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
K
01
1875
MODIFICATION TO THE TAC' PIN
K
01
1319
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K
01
1137
RESORBABLE HAMMERTOE PIN
K
01
1136
APEX FIXATION PINS
K
00
2605
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
K
00
3294
BIOMET LATERAL TROCH PLATE
K
00
3131
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K
00
1720
SYNTHES SACRAL BAR SYSTEM
K
00
1886
APEX FIXATION PINS
K
00
1228
EXTERNAL FIXATION ANCHOR PIN
K
99
4143
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
K
99
3910
TAC' PIN
K
99
2970
DIGIT WIDGET
K
99
1649
DEPUY ROCKWOOD CLAVICLE PIN
K
99
0353
STAINLESS STEEL FIXATION PINS
K
98
3757
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01
K
98
2931
THREADED FIXATION PIN
K
98
2068
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
K
98
1716
EXTERNAL FIXATION
K
98
0788
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
K
97
4186
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
K
97
4911
EXTERNAL FIXATOR
K
97
0751
HEIDELBERG EXTERNAL FIXATOR
K
97
0713
COMPASS UNIVERSAL HINGE
K
97
0097
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
K
96
4893
HANSSON PIN SYSTEM
K
96
3973
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
K
96
3433
THREADED FIXATION PIN
K
96
1920
CROSS PIN
K
95
5848
ORTHOFIX MODULSYSTEM
K
96
0023
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
K
95
5780
RIGIDYNE A EXTERNAL FIXATION SYSTEM
K
95
4630
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM
K
95
0009
POWERGRIP(TM) COMPRESSION FIXATION DEVICE
K
95
2640
CANNULATED PLUS HIP SCREW
K
94
6228
CROSS PIN SCREW SYSTEM
K
94
5670
KIRSCHNER (K-WIRE), STEINMAN PINS
K
93
2349
ORTHOPEDIC THREADED PIN FIXATION
K
90
5347
HAGIE PIN
K
90
5336
STEINMAN PIN, THREADED
K
90
5344
KNOWLES PIN
K
90
3261
RUSH PIN
K
90
3266
STEINMAN PIN, THREAD
K
89
5173
SKELETAL FIXATION PIN
K
88
1511
FIXATOR PIN (EXTERNAL)
K
87
5013
ACE PERCUTANEOUS 3MM HALF-PINS
K
87
5022
ACE/FISHER PERCUTANEOUS TRANSFIXING PINS
K
87
5012
ACE/FISCHER PERCUTANEOUS HALF PINS
K
87
5021
ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM
K
86
1766
HOWMEDICA HOFFMANN FIXATION PIN SYSTEM
K
84
2293
PARTIALLY THREADED BONE FIX. PIN
K
84
0286
BROOKER EXTERNAL FIXATION FRAME
K
83
3907
CREIGHTON FIXATOR
K
78
1251
THREADED PIN, SELF DRILLING
K
76
0454
GOUFFON PIN, ADJUSTABLE
JEC
Component, Traction, Invasive
JWH
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
JWI
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
JWJ
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
KIG
Prosthesis, Wrist, Constrained, Polymer
KMB
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
KMC
Prosthesis, Hip, Semi-Constrained, Composite/Metal
KMD
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite
KRN
Metal Cemented Constrained Femorotibial Knee Prosthesis
KRO
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
KRP
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
KRQ
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
KRR
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
KRS
Prosthesis, Knee, Hemi-, Femoral (Uncemented)
KTT
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTW
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
KTX
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
KWA
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
KWB
Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
KWD
Prosthesis, Toe, Hemi-, Phalangeal
KWE
Prosthesis, Finger, Constrained, Metal, Uncemented
KWF
Prosthesis, Finger, Polymer
KWG
Prosthesis, Finger, Constrained, Metal/Polymer
KWH
Prosthesis, Toe, Constrained, Polymer
KWI
Prosthesis, Elbow, Hemi-, Radial, Polymer
KWJ
Prosthesis, Elbow, Hemi-, Humeral, Metal
KWK
Appliance, Nail/Blade/Plate Combination, Single Component
KWL
Prosthesis, Hip, Hemi-, Femoral, Metal
KWM
Prosthesis, Wrist, Semi-Constrained
KWN
Prosthesis, Wrist, Carpal Lunate
KWO
Prosthesis, Wrist, Carpal Scaphoid
KWP
Appliance, Fixation, Spinal Interlaminal
KWQ
Appliance, Fixation, Spinal Intervertebral Body
KWR
Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
KWS
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWT
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
KWY
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWZ
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
KXA
Prosthesis, Hip, Femoral, Resurfacing
KXB
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer
KXC
Prosthesis, Ankle, Cemented, Non-Constrained
KXD
Prosthesis, Hip, Constrained, Metal
KXE
Prosthesis, Wrist, Hemi-, Ulnar
KYI
Prosthesis, Wrist, Carpal Trapezium
KYJ
Prosthesis, Finger, Constrained, Polymer
KYK
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
KYM
Metallic Cemented Glenoid Hemi-Shoulder Prosthesis
KYN
Prosthesis, Wrist, Constrained, Metal
LBC
Prosthesis, Finger, Constrained, Metal, Cemented
LGE
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
LOD
Bone Cement
LPH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LRN
Wire, Surgical
LTO
Spacer, Cement
LWJ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LXT
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
LYP
Accessories, Fixation, Spinal Interlaminal
LYT
Fixation Accessory
LZO
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
LZY
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
MAI
Fastener, Fixation, Biodegradable, Soft Tissue
MAX
Intervertebral Fusion Device With Bone Graft, Lumbar
MAY
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
MBB
Bone Cement, Antibiotic
MBF
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
MBH
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
MBI
Fastener, Fixation, Nondegradable, Soft Tissue
MBL
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
MBP
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
MBV
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
MEH
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
MJW
Prosthesis, Subtalar, Plug, Polymer
MNH
Orthosis, Spondylolisthesis Spinal Fixation
MNI
Orthosis, Spinal Pedicle Fixation
MNU
Staple, Absorbable
MQP
Spinal Vertebral Body Replacement Device
MQV
Filler, Bone Void, Calcium Compound
MRY
Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component
NDD
Cerclage, Fixation, Metallic
NDE
Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible
NDF
Plate, Fixation, Bone, Non-Spinal, Metallic
NDG
Washer, Bolt, Nut, Non-Spinal, Metallic
NDJ
Screw, Fixation, Bone, Non-Spinal, Metallic
NDK
System, External Fixator (With Metallic Invasive Components)
NDL
Pin, Fixation, Smooth, Metallic
NDM
Pin, Fixation, Threaded, Metallic
NDN
Cement, Bone, Vertebroplasty
NJA
Accessory, System, External Fixator, Containing Antimicrobial Agent
NJD
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
NKB
Thoracolumbosacral Pedicle Screw System
NKG
Posterior Cervical Screw System
NOV
Anchor, Suture, Bone Fixation, Metallic
NPJ
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NQP
Posterior Metal/Polymer Spinal System, Fusion
NQW
Orthosis, Spine, Plate, Laminoplasty, Metal
NUD
Vertebroplasty Compound, Calcium Based
NVC
Bone, Heterograft
NWN
Laparoscopic Bone Anchor Urethropexy Instrument Kit
OBL
Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
OBM
Cement, Bone, Vertebroplasty, Pre-Formed, Modular
OBT
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
OCG
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
ODP
Intervertebral Fusion Device With Bone Graft, Cervical
OIS
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
OIY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
OJB
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
OJM
Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
OOG
Knee Arthroplasty Implantation System
OOL
Electronic Depth Gauge
OQB
Intervertebral Body Graft Containment Device
OQG
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
OQH
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
OQI
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
OSH
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
OSN
Software For Diagnosis/Treatment
OUR
Sacroiliac Joint Fixation
OVD
Intervertebral Fusion Device With Integrated Fixation, Lumbar
OVE
Intervertebral Fusion Device With Integrated Fixation, Cervical
OVZ
Pin, Fixation, Resorbable, Hard Tissue
OWI
Bone Fixation Cerclage, Sublaminar
OYK
Ankle Arthroplasty Implantation System
OZI
Internal Hinged Elbow Fixator
PAO
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
PBF
Orthopaedic Surgical Planning And Instrument Guides
PBI
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
PEK
Spinous Process Plate
PHM
Intervertebral Fusion Device With Bone Graft, Thoracic
PHQ
Anterior Staple As Supplemental Fixation For Fusion
PHX
Shoulder Prosthesis, Reverse Configuration
PKC
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PLF
Bone Wedge
PLR
Spinal Vertebral Body Replacement Device - Cervical
PLW
Acetabular Cup Orientation System
PML
Bone Cement, Posterior Screw Augmentation
PPQ
Transtibial Anterior Cruciate Ligament Kit
QHQ
Total Shoulder Arthroplasty System
PQC
Pedicle Screw Placement Guide
QAC
Screw Sleeve Bone Fixation Device
QAD
Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
QFP
Intraoperative Orthopedic Strain Sensor
QHE
Shoulder Arthroplasty Implantation System
QNI
Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
QPP
Implantable Post-Surgical Kinematic Measurement Knee Device
QPQ
Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
JDJ
Mesh, Surgical, Acetabular, Hip, Prosthesis
JDK
Prosthesis, Hip, Cement Restrictor
LZN
Cement Obturator
OLC
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
QSD
Posterior Cervical Screw Placement Guide
QSR
Sacroiliac Screw Placement Guide
QVI
Screw Sleeve Bone Fixation Device, Spine
QUW
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
QWJ
Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
SAI
Ankle Fusion Cage
SCY
Sacroiliac Joint Guidewire Placement Device
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OR
/
subpart-d—prosthetic-devices
/
JDW
/
K103001
View Source
ROCKWOOD CLAVICLE PINS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103001
510(k) Type
Traditional
Applicant
DEPUY ORTHOPAEDICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/17/2011
Days to Decision
134 days
Submission Type
Summary