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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
JEC
Component, Traction, Invasive
2
Product Code
K
20
3605
SteriTrak
2
Cleared 510(K)
K
19
3256
Anjon Bremer Halo System
2
Cleared 510(K)
K
19
2465
DigiFix Sterile Kit
2
Cleared 510(K)
K
18
1192
PIP Fix
2
Cleared 510(K)
K
17
1863
Anjon Bremer Halo System
2
Cleared 510(K)
K
16
3028
Medline ReNewal Reprocessed Stryker External Fixation Devices
2
Cleared 510(K)
K
13
2731
DIGIFIX EXTERNAL FIXATION SYSTEM
2
Cleared 510(K)
K
10
2885
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
2
Cleared 510(K)
K
08
2679
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
2
Cleared 510(K)
K
07
2432
F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
2
Cleared 510(K)
K
07
1476
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
2
Cleared 510(K)
K
04
2066
KLSA MARTIN HAND DISTRACTOR
2
Cleared 510(K)
K
03
2427
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
2
Cleared 510(K)
K
03
1941
HOFFMANN II COMPACT BALTIMORE COUPLING
2
Cleared 510(K)
K
03
0519
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
2
Cleared 510(K)
K
02
2676
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
2
Cleared 510(K)
K
02
2065
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
2
Cleared 510(K)
K
01
2193
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
2
Cleared 510(K)
K
01
3818
AUTOGENESIS AUTOMATOR, MODEL M1000
2
Cleared 510(K)
K
00
3848
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
2
Cleared 510(K)
K
99
3099
BREMER HALO SYSTEM TITANIUM SKULL PIN
2
Cleared 510(K)
K
99
1732
CENTRAFIX EXTERNAL FIXATOR
2
Cleared 510(K)
K
98
4442
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
2
Cleared 510(K)
K
98
1423
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
2
Cleared 510(K)
K
97
1755
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
2
Cleared 510(K)
K
96
5029
STABLELOC II EXTERNAL FIXATOR
2
Cleared 510(K)
K
96
3614
MONOTUBE CARBON TUBE
2
Cleared 510(K)
K
96
1916
HOFFMANN II CARBON CONNECTING ROD
2
Cleared 510(K)
K
96
1618
MONOTUBE TUBE TO RING CLAMP
2
Cleared 510(K)
K
96
0782
TITANIUM TUBE TO TUBE CLAMP
2
Cleared 510(K)
K
95
4838
EZ FIX
2
Cleared 510(K)
K
95
4667
MONOTUBE TUBE-TO-TUBE CLAMP
2
Cleared 510(K)
K
95
2330
EXTERNAL FIXATOR
2
Cleared 510(K)
K
95
2730
HOFFMANN II EXTERNAL FIXATION SYSTEM
2
Cleared 510(K)
K
94
4092
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
2
Cleared 510(K)
K
94
3857
EXTERNAL FIXATOR
2
Cleared 510(K)
K
93
3968
ACE PELVIC STABILIZER
2
Cleared 510(K)
K
92
2796
PELVIC C-CLAMP
2
Cleared 510(K)
K
93
6124
HOWMEDICA MONOTUBE T-CONNECTOR
2
Cleared 510(K)
K
93
6045
ACE UNILATERAL FIXATOR II
2
Cleared 510(K)
K
93
4698
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
2
Cleared 510(K)
K
93
1578
TEXAS SCOTTISH RITE EASY/LOCK FIXATOR
2
Cleared 510(K)
K
93
0153
SYSTEM III HALO RING
2
Cleared 510(K)
K
92
0117
HALO ESPRIT
2
Cleared 510(K)
K
92
0149
OSTEO EX-FI-RE
2
Cleared 510(K)
K
91
5800
BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN
2
Cleared 510(K)
K
91
4858
ACE OPEN-BACK HALO RING
2
Cleared 510(K)
K
89
4959
CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO
2
Cleared 510(K)
K
90
3105
OLIVE K-WIRES
2
Cleared 510(K)
K
90
1984
ACE WIRE TENSION CLAMP
2
Cleared 510(K)
K
89
4098
SYNTHES EXTERNAL FIXATION BONE CLIP
2
Cleared 510(K)
K
89
4982
ACE WIRE TENSION CLAMP
2
Cleared 510(K)
K
89
2638
TRACER DYNAMIC AXIAL FIXATION
2
Cleared 510(K)
K
88
4798
AME PINSITE SHIELD(TM)
2
Cleared 510(K)
K
88
4242
MODIFIED CHICK AMBULATORY HALO
2
Cleared 510(K)
K
88
2877
JMS CERVICAL TRACTION DEVICE/HALO DEVICE
2
Cleared 510(K)
K
88
1896
KIRSCHNER SUPER-FIXATION SYSTEM
2
Cleared 510(K)
K
88
1673
LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER
2
Cleared 510(K)
K
88
0282
LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER
2
Cleared 510(K)
K
87
2538
VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS
2
Cleared 510(K)
K
85
2397
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
2
Cleared 510(K)
K
84
2493
AGEE EXTERNAL FIXATOR
2
Cleared 510(K)
K
84
2343
SABA-COOMBS MINI EXTERNAL FIXATOR
2
Cleared 510(K)
K
84
1334
RICHARDS FIXATOR SYSTEM
2
Cleared 510(K)
K
84
0856
MODULAR CONSTRUCT FRAME EXTERNAL FIXA
2
Cleared 510(K)
K
83
3114
OXFORD MARK 2 EXTERNAL FIXATOR
2
Cleared 510(K)
K
83
1576
ORTHOFIX
2
Cleared 510(K)
K
83
0154
COLLES FRACTURE FRAME
2
Cleared 510(K)
K
82
2780
CERVICAL BRACE
2
Cleared 510(K)
K
80
3166
DOUBLE BALL JOINT
2
Cleared 510(K)
K
80
2814
ORTHOFIX AXIALEXTERNAL FIXATION SYS.
2
Cleared 510(K)
K
80
2776
HOFFMAN LEG LENGTHENING DEVICE
2
Cleared 510(K)
K
80
2722
EXTERNAL FIXATION SYSTEM
2
Cleared 510(K)
K
80
2723
EXTENDED BALLJOINT GRIP
2
Cleared 510(K)
K
80
0184
OXFORD EXTERNAL FIXATION SYSTEM
2
Cleared 510(K)
K
79
2561
MINI-H-FIXATION
2
Cleared 510(K)
K
79
1466
ACE EXTERNAL BONE CLAMP PART #S11
2
Cleared 510(K)
K
79
0262
UNIVERSAL EXTERNAL FIXATION ASSEMBLY
2
Cleared 510(K)
K
78
1839
BONE CLAMP, ACE EXTERNAL
2
Cleared 510(K)
K
78
1841
BAR, DISTRACTION
2
Cleared 510(K)
K
78
1840
EXTERNAL ARTICULATION
2
Cleared 510(K)
K
78
1793
FRAME, UNIVERSAL DAY
2
Cleared 510(K)
K
77
0066
TIBIAL COMPRESSION FRAM FOR FRACTURES
2
Cleared 510(K)
K
77
0388
FRACTURE REDUCTION SYS., MODEL OR 1001
2
Cleared 510(K)
K
76
1088
DEPUY MODIFIED SKELETAL TRACTION PIN
2
Cleared 510(K)
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 23 May 2025 at 11:06 pm
OR
/
subpart-d—prosthetic-devices
/
JEC
/
K954667
View Source
MONOTUBE TUBE-TO-TUBE CLAMP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K954667
510(k) Type
Traditional
Applicant
HOWMEDICA CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/11/1996
Days to Decision
93 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
JEC
Component, Traction, Invasive
K
20
3605
SteriTrak
K
19
3256
Anjon Bremer Halo System
K
19
2465
DigiFix Sterile Kit
K
18
1192
PIP Fix
K
17
1863
Anjon Bremer Halo System
K
16
3028
Medline ReNewal Reprocessed Stryker External Fixation Devices
K
13
2731
DIGIFIX EXTERNAL FIXATION SYSTEM
K
10
2885
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
K
08
2679
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
K
07
2432
F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
K
07
1476
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
K
04
2066
KLSA MARTIN HAND DISTRACTOR
K
03
2427
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
K
03
1941
HOFFMANN II COMPACT BALTIMORE COUPLING
K
03
0519
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
K
02
2676
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K
02
2065
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
K
01
2193
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K
01
3818
AUTOGENESIS AUTOMATOR, MODEL M1000
K
00
3848
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K
99
3099
BREMER HALO SYSTEM TITANIUM SKULL PIN
K
99
1732
CENTRAFIX EXTERNAL FIXATOR
K
98
4442
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
K
98
1423
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
K
97
1755
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
K
96
5029
STABLELOC II EXTERNAL FIXATOR
K
96
3614
MONOTUBE CARBON TUBE
K
96
1916
HOFFMANN II CARBON CONNECTING ROD
K
96
1618
MONOTUBE TUBE TO RING CLAMP
K
96
0782
TITANIUM TUBE TO TUBE CLAMP
K
95
4838
EZ FIX
K
95
4667
MONOTUBE TUBE-TO-TUBE CLAMP
K
95
2330
EXTERNAL FIXATOR
K
95
2730
HOFFMANN II EXTERNAL FIXATION SYSTEM
K
94
4092
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
K
94
3857
EXTERNAL FIXATOR
K
93
3968
ACE PELVIC STABILIZER
K
92
2796
PELVIC C-CLAMP
K
93
6124
HOWMEDICA MONOTUBE T-CONNECTOR
K
93
6045
ACE UNILATERAL FIXATOR II
K
93
4698
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K
93
1578
TEXAS SCOTTISH RITE EASY/LOCK FIXATOR
K
93
0153
SYSTEM III HALO RING
K
92
0117
HALO ESPRIT
K
92
0149
OSTEO EX-FI-RE
K
91
5800
BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN
K
91
4858
ACE OPEN-BACK HALO RING
K
89
4959
CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO
K
90
3105
OLIVE K-WIRES
K
90
1984
ACE WIRE TENSION CLAMP
K
89
4098
SYNTHES EXTERNAL FIXATION BONE CLIP
K
89
4982
ACE WIRE TENSION CLAMP
K
89
2638
TRACER DYNAMIC AXIAL FIXATION
K
88
4798
AME PINSITE SHIELD(TM)
K
88
4242
MODIFIED CHICK AMBULATORY HALO
K
88
2877
JMS CERVICAL TRACTION DEVICE/HALO DEVICE
K
88
1896
KIRSCHNER SUPER-FIXATION SYSTEM
K
88
1673
LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER
K
88
0282
LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER
K
87
2538
VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS
K
85
2397
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
K
84
2493
AGEE EXTERNAL FIXATOR
K
84
2343
SABA-COOMBS MINI EXTERNAL FIXATOR
K
84
1334
RICHARDS FIXATOR SYSTEM
K
84
0856
MODULAR CONSTRUCT FRAME EXTERNAL FIXA
K
83
3114
OXFORD MARK 2 EXTERNAL FIXATOR
K
83
1576
ORTHOFIX
K
83
0154
COLLES FRACTURE FRAME
K
82
2780
CERVICAL BRACE
K
80
3166
DOUBLE BALL JOINT
K
80
2814
ORTHOFIX AXIALEXTERNAL FIXATION SYS.
K
80
2776
HOFFMAN LEG LENGTHENING DEVICE
K
80
2722
EXTERNAL FIXATION SYSTEM
K
80
2723
EXTENDED BALLJOINT GRIP
K
80
0184
OXFORD EXTERNAL FIXATION SYSTEM
K
79
2561
MINI-H-FIXATION
K
79
1466
ACE EXTERNAL BONE CLAMP PART #S11
K
79
0262
UNIVERSAL EXTERNAL FIXATION ASSEMBLY
K
78
1839
BONE CLAMP, ACE EXTERNAL
K
78
1841
BAR, DISTRACTION
K
78
1840
EXTERNAL ARTICULATION
K
78
1793
FRAME, UNIVERSAL DAY
K
77
0066
TIBIAL COMPRESSION FRAM FOR FRACTURES
K
77
0388
FRACTURE REDUCTION SYS., MODEL OR 1001
K
76
1088
DEPUY MODIFIED SKELETAL TRACTION PIN
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
/
JEC
/
K954667
View Source
MONOTUBE TUBE-TO-TUBE CLAMP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K954667
510(k) Type
Traditional
Applicant
HOWMEDICA CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/11/1996
Days to Decision
93 days
Submission Type
Summary