Anesthesiology
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- ImmunologyReview Panel
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- OphthalmicReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- NDHNail, Fixation, Bone, Metallic2Product Code
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HRZProsthesis, Knee, Hinged (Metal-Metal)3Product Code
- HSAProsthesis, Knee, Hemi-, Femoral3Product Code
- HSBRod, Fixation, Intramedullary And Accessories2Product Code
- NDIStaple, Fixation, Bone, Metallic2Product Code
- HRSPlate, Fixation, Bone2Product Code
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2Product Code
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)2Product Code
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer2Product Code
- HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented2Product Code
- HTNWasher, Bolt Nut2Product Code
- HTYPin, Fixation, Smooth2Product Code
- HWCScrew, Fixation, Bone2Product Code
- HXAProsthesis, Tendon, Passive2Product Code
- JDBProsthesis, Elbow, Semi-Constrained, Cemented2Product Code
- JDCProsthesis, Elbow, Constrained, Cemented2Product Code
- JDDProsthesis, Upper Femoral2Product Code
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal2Product Code
- JDHProsthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal3Product Code
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2Product Code
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)3Product Code
- JDNImplant, Fixation Device, Spinal2Product Code
- JDODevice, Fixation, Proximal Femoral, Implant2Product Code
- JDPCondylar Plate Fixation Implant2Product Code
- JDQCerclage, Fixation2Product Code
- JDRStaple, Fixation, Bone2Product Code
- JDSNail, Fixation, Bone2Product Code
- JDTCap, Bone1Product Code
- JDWPin, Fixation, Threaded2Product Code
- JECComponent, Traction, Invasive2Product Code
- K203605SteriTrak2Cleared 510(K)
- K193256Anjon Bremer Halo System2Cleared 510(K)
- K192465DigiFix Sterile Kit2Cleared 510(K)
- K181192PIP Fix2Cleared 510(K)
- K171863Anjon Bremer Halo System2Cleared 510(K)
- K163028Medline ReNewal Reprocessed Stryker External Fixation Devices2Cleared 510(K)
- K132731DIGIFIX EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K102885HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX2Cleared 510(K)
- K082679LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X2Cleared 510(K)
- K072432F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE2Cleared 510(K)
- K071476SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP2Cleared 510(K)
- K042066KLSA MARTIN HAND DISTRACTOR2Cleared 510(K)
- K032427FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM2Cleared 510(K)
- K031941HOFFMANN II COMPACT BALTIMORE COUPLING2Cleared 510(K)
- K030519WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS2Cleared 510(K)
- K022676ORTHOGUARD AB ANTIMICROBIAL SLEEVE2Cleared 510(K)
- K022065SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X2Cleared 510(K)
- K012193AMC ANTIMICROBIAL PIN/WIRE SLEEVE2Cleared 510(K)
- K013818AUTOGENESIS AUTOMATOR, MODEL M10002Cleared 510(K)
- K003848HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST2Cleared 510(K)
- K993099BREMER HALO SYSTEM TITANIUM SKULL PIN2Cleared 510(K)
- K991732CENTRAFIX EXTERNAL FIXATOR2Cleared 510(K)
- K984442AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-1472Cleared 510(K)
- K981423AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC20002Cleared 510(K)
- K971755HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K965029STABLELOC II EXTERNAL FIXATOR2Cleared 510(K)
- K963614MONOTUBE CARBON TUBE2Cleared 510(K)
- K961916HOFFMANN II CARBON CONNECTING ROD2Cleared 510(K)
- K961618MONOTUBE TUBE TO RING CLAMP2Cleared 510(K)
- K960782TITANIUM TUBE TO TUBE CLAMP2Cleared 510(K)
- K954838EZ FIX2Cleared 510(K)
- K954667MONOTUBE TUBE-TO-TUBE CLAMP2Cleared 510(K)
- K952330EXTERNAL FIXATOR2Cleared 510(K)
- K952730HOFFMANN II EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K944092ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM2Cleared 510(K)
- K943857EXTERNAL FIXATOR2Cleared 510(K)
- K933968ACE PELVIC STABILIZER2Cleared 510(K)
- K922796PELVIC C-CLAMP2Cleared 510(K)
- K936124HOWMEDICA MONOTUBE T-CONNECTOR2Cleared 510(K)
- K936045ACE UNILATERAL FIXATOR II2Cleared 510(K)
- K934698HOWMEDICA MONO-TUBE SINGLE PIN CLAMP2Cleared 510(K)
- K931578TEXAS SCOTTISH RITE EASY/LOCK FIXATOR2Cleared 510(K)
- K930153SYSTEM III HALO RING2Cleared 510(K)
- K920117HALO ESPRIT2Cleared 510(K)
- K920149OSTEO EX-FI-RE2Cleared 510(K)
- K915800BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN2Cleared 510(K)
- K914858ACE OPEN-BACK HALO RING2Cleared 510(K)
- K894959CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO2Cleared 510(K)
- K903105OLIVE K-WIRES2Cleared 510(K)
- K901984ACE WIRE TENSION CLAMP2Cleared 510(K)
- K894098SYNTHES EXTERNAL FIXATION BONE CLIP2Cleared 510(K)
- K894982ACE WIRE TENSION CLAMP2Cleared 510(K)
- K892638TRACER DYNAMIC AXIAL FIXATION2Cleared 510(K)
- K884798AME PINSITE SHIELD(TM)2Cleared 510(K)
- K884242MODIFIED CHICK AMBULATORY HALO2Cleared 510(K)
- K882877JMS CERVICAL TRACTION DEVICE/HALO DEVICE2Cleared 510(K)
- K881896KIRSCHNER SUPER-FIXATION SYSTEM2Cleared 510(K)
- K881673LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER2Cleared 510(K)
- K880282LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER2Cleared 510(K)
- K872538VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS2Cleared 510(K)
- K852397EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)2Cleared 510(K)
- K842493AGEE EXTERNAL FIXATOR2Cleared 510(K)
- K842343SABA-COOMBS MINI EXTERNAL FIXATOR2Cleared 510(K)
- K841334RICHARDS FIXATOR SYSTEM2Cleared 510(K)
- K840856MODULAR CONSTRUCT FRAME EXTERNAL FIXA2Cleared 510(K)
- K833114OXFORD MARK 2 EXTERNAL FIXATOR2Cleared 510(K)
- K831576ORTHOFIX2Cleared 510(K)
- K830154COLLES FRACTURE FRAME2Cleared 510(K)
- K822780CERVICAL BRACE2Cleared 510(K)
- K803166DOUBLE BALL JOINT2Cleared 510(K)
- K802814ORTHOFIX AXIALEXTERNAL FIXATION SYS.2Cleared 510(K)
- K802776HOFFMAN LEG LENGTHENING DEVICE2Cleared 510(K)
- K802723EXTENDED BALLJOINT GRIP2Cleared 510(K)
- K802722EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K800184OXFORD EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K792561MINI-H-FIXATION2Cleared 510(K)
- K791466ACE EXTERNAL BONE CLAMP PART #S112Cleared 510(K)
- K790262UNIVERSAL EXTERNAL FIXATION ASSEMBLY2Cleared 510(K)
- K781839BONE CLAMP, ACE EXTERNAL2Cleared 510(K)
- K781841BAR, DISTRACTION2Cleared 510(K)
- K781840EXTERNAL ARTICULATION2Cleared 510(K)
- K781793FRAME, UNIVERSAL DAY2Cleared 510(K)
- K770066TIBIAL COMPRESSION FRAM FOR FRACTURES2Cleared 510(K)
- K770388FRACTURE REDUCTION SYS., MODEL OR 10012Cleared 510(K)
- K761088DEPUY MODIFIED SKELETAL TRACTION PIN2Cleared 510(K)
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained2Product Code
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2Product Code
- KIGProsthesis, Wrist, Constrained, Polymer2Product Code
- KMBProsthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented2Product Code
- KMCProsthesis, Hip, Semi-Constrained, Composite/Metal2Product Code
- KMDProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KRNMetal Cemented Constrained Femorotibial Knee Prosthesis3Product Code
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2Product Code
- KRPProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal3Product Code
- KRQProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- KRSProsthesis, Knee, Hemi-, Femoral (Uncemented)3Product Code
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2Product Code
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component2Product Code
- KTXProsthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented2Product Code
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)3Product Code
- KWBProsthesis, Hip, Hemi-, Acetabular, Cemented, Metal3Product Code
- KWDProsthesis, Toe, Hemi-, Phalangeal2Product Code
- KWEProsthesis, Finger, Constrained, Metal, Uncemented3Product Code
- KWFProsthesis, Finger, Polymer2Product Code
- KWGProsthesis, Finger, Constrained, Metal/Polymer3Product Code
- KWHProsthesis, Toe, Constrained, Polymer2Product Code
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer2Product Code
- KWJProsthesis, Elbow, Hemi-, Humeral, Metal3Product Code
- KWKAppliance, Nail/Blade/Plate Combination, Single Component2Product Code
- KWLProsthesis, Hip, Hemi-, Femoral, Metal2Product Code
- KWMProsthesis, Wrist, Semi-Constrained2Product Code
- KWNProsthesis, Wrist, Carpal Lunate2Product Code
- KWOProsthesis, Wrist, Carpal Scaphoid2Product Code
- KWPAppliance, Fixation, Spinal Interlaminal2Product Code
- KWQAppliance, Fixation, Spinal Intervertebral Body2Product Code
- KWRProsthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented3Product Code
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2Product Code
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2Product Code
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2Product Code
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2Product Code
- KXAProsthesis, Hip, Femoral, Resurfacing2Product Code
- KXBProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer3Product Code
- KXCProsthesis, Ankle, Cemented, Non-Constrained3Product Code
- KXDProsthesis, Hip, Constrained, Metal3Product Code
- KXEProsthesis, Wrist, Hemi-, Ulnar2Product Code
- KYIProsthesis, Wrist, Carpal Trapezium2Product Code
- KYJProsthesis, Finger, Constrained, Polymer2Product Code
- KYKProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis3Product Code
- KYNProsthesis, Wrist, Constrained, Metal3Product Code
- LBCProsthesis, Finger, Constrained, Metal, Cemented3Product Code
- LGEProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing2Product Code
- LODBone Cement2Product Code
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2Product Code
- LRNWire, Surgical2Product Code
- LTOSpacer, Cement3Product Code
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite2Product Code
- LYPAccessories, Fixation, Spinal Interlaminal2Product Code
- LYTFixation Accessory2Product Code
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2Product Code
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball2Product Code
- MAIFastener, Fixation, Biodegradable, Soft Tissue2Product Code
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar2Product Code
- MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish2Product Code
- MBBBone Cement, Antibiotic2Product Code
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer2Product Code
- MBIFastener, Fixation, Nondegradable, Soft Tissue2Product Code
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous2Product Code
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)2Product Code
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer2Product Code
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2Product Code
- MJWProsthesis, Subtalar, Plug, Polymer2Product Code
- MNHOrthosis, Spondylolisthesis Spinal Fixation2Product Code
- MNIOrthosis, Spinal Pedicle Fixation2Product Code
- MNUStaple, Absorbable2Product Code
- MQPSpinal Vertebral Body Replacement Device2Product Code
- MQVFiller, Bone Void, Calcium Compound2Product Code
- MRYAppliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component2Product Code
- NDDCerclage, Fixation, Metallic2Product Code
- NDERod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible2Product Code
- NDFPlate, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic2Product Code
- NDJScrew, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDKSystem, External Fixator (With Metallic Invasive Components)2Product Code
- NDLPin, Fixation, Smooth, Metallic2Product Code
- NDMPin, Fixation, Threaded, Metallic2Product Code
- NDNCement, Bone, Vertebroplasty2Product Code
- NJAAccessory, System, External Fixator, Containing Antimicrobial Agent2Product Code
- NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer2Product Code
- NKBThoracolumbosacral Pedicle Screw System2Product Code
- NKGPosterior Cervical Screw System2Product Code
- NOVAnchor, Suture, Bone Fixation, Metallic2Product Code
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- NQPPosterior Metal/Polymer Spinal System, Fusion2Product Code
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal2Product Code
- NUDVertebroplasty Compound, Calcium Based2Product Code
- NVCBone, Heterograft3Product Code
- NWNLaparoscopic Bone Anchor Urethropexy Instrument Kit2Product Code
- OBLCement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty2Product Code
- OBMCement, Bone, Vertebroplasty, Pre-Formed, Modular2Product Code
- OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis2Product Code
- OCGProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented3Product Code
- ODPIntervertebral Fusion Device With Bone Graft, Cervical2Product Code
- OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation2Product Code
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2Product Code
- OJBResorbable Spinal Intervertebral Body Fixation Orthosis - Plate2Product Code
- OJMResorbable Spinal Intervertebral Body Fixation Orthosis - Mesh2Product Code
- OOGKnee Arthroplasty Implantation System2Product Code
- OOLElectronic Depth Gauge2Product Code
- OQBIntervertebral Body Graft Containment Device2Product Code
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented2Product Code
- OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented2Product Code
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2Product Code
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis2Product Code
- OSNSoftware For Diagnosis/Treatment2Product Code
- OURSacroiliac Joint Fixation2Product Code
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2Product Code
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2Product Code
- OVZPin, Fixation, Resorbable, Hard Tissue2Product Code
- OWIBone Fixation Cerclage, Sublaminar2Product Code
- OYKAnkle Arthroplasty Implantation System2Product Code
- OZIInternal Hinged Elbow Fixator2Product Code
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented2Product Code
- PBFOrthopaedic Surgical Planning And Instrument Guides2Product Code
- PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive2Product Code
- PEKSpinous Process Plate2Product Code
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic2Product Code
- PHQAnterior Staple As Supplemental Fixation For Fusion2Product Code
- PHXShoulder Prosthesis, Reverse Configuration2Product Code
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained2Product Code
- PLFBone Wedge2Product Code
- PLRSpinal Vertebral Body Replacement Device - Cervical2Product Code
- PLWAcetabular Cup Orientation System2Product Code
- PMLBone Cement, Posterior Screw Augmentation2Product Code
- PPQTranstibial Anterior Cruciate Ligament Kit2Product Code
- QHQTotal Shoulder Arthroplasty System2Product Code
- PQCPedicle Screw Placement Guide2Product Code
- QACScrew Sleeve Bone Fixation Device2Product Code
- QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated2Product Code
- QFPIntraoperative Orthopedic Strain Sensor2Product Code
- QHEShoulder Arthroplasty Implantation System2Product Code
- QNIResorbable Implant For Anterior Cruciate Ligament (Acl) Repair2Product Code
- QPPImplantable Post-Surgical Kinematic Measurement Knee Device2Product Code
- QPQShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed2Product Code
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis2Product Code
- JDKProsthesis, Hip, Cement Restrictor2Product Code
- LZNCement Obturator2Product Code
- OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen2Product Code
- QSDPosterior Cervical Screw Placement Guide2Product Code
- QSRSacroiliac Screw Placement Guide2Product Code
- QVIScrew Sleeve Bone Fixation Device, Spine2Product Code
- QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- SAIAnkle Fusion Cage2Product Code
- SCYSacroiliac Joint Guidewire Placement Device2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
AGEE EXTERNAL FIXATOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K842493
- 510(k) Type
- Traditional
- Applicant
- THE HAND BIOMECHANICS RESEARCH LABORATORY
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/13/1985
- Days to Decision
- 232 days