Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- 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
- K250712Linkt Compression Staple System2Cleared 510(K)
- K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant System2Cleared 510(K)
- K243742Arthrex DynaNite Nitinol Staples2Cleared 510(K)
- K243658TMC Compression Implant System2Cleared 510(K)
- K242415TMC Compression Implant System2Cleared 510(K)
- K240212COGNiTiON™ Staple System2Cleared 510(K)
- K232990A’TOMIC™ Nitinol Fixation System2Cleared 510(K)
- K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staples2Cleared 510(K)
- K232905Medline UNITE® REFLEX® Nitinol Staple Kit2Cleared 510(K)
- K232324StealthFix Intraosseous Fixation System2Cleared 510(K)
- K232387Treace Medical Concepts (TMC) Compression Implant System2Cleared 510(K)
- K231493NITINEX Memory Compression Staple2Cleared 510(K)
- K231885Medline UNITE® REFLEX® Nitinol Staple System2Cleared 510(K)
- K231458Extremity Staple2Cleared 510(K)
- K230550JAWS Nitinol Staple System2Cleared 510(K)
- K223056JAWS Nitinol Staple System2Cleared 510(K)
- K222645Treace Medical Concepts (TMC) Implant Fixation System2Cleared 510(K)
- K221947Tyber Medical Staple Fixation System (various)2Cleared 510(K)
- K220812DynaClip® Bone Staple2Cleared 510(K)
- K210582EasyClip® and EasyClip® Xpress2Cleared 510(K)
- K220181StealthFix Intraosseous Fixation System2Cleared 510(K)
- K203832FuseForce™ Flex Dynamic Compression System2Cleared 510(K)
- K210482Medline UNITE REFLEX Nitinol Staple System2Cleared 510(K)
- K210456Ligament Staple2Cleared 510(K)
- K203180Arthrex DynaNite Nitinol Staples2Cleared 510(K)
- K193305DynaClip Bone Staple2Cleared 510(K)
- K192447Superelastic Staple2Cleared 510(K)
- K191463DePuy Synthes Hammertoe Continuous Compression Implant2Cleared 510(K)
- K191636APTUS Foot System2Cleared 510(K)
- K190722TriMAX Implant System2Cleared 510(K)
- K190166TriMed Nitinol Staple System2Cleared 510(K)
- K182943VERTEX Nitinol Staple System2Cleared 510(K)
- K182212Geo Staple System2Cleared 510(K)
- K181781DynaClipTM Bone Staple2Cleared 510(K)
- K181815DynaBridge2Cleared 510(K)
- K181866MotoCLIP/HiMAX Step Staple Implant System2Cleared 510(K)
- K180544DePuy Synthes Static Staples2Cleared 510(K)
- K181410MotoCLIP/HiMAX Implant System2Cleared 510(K)
- K173775Clench Compression Staple2Cleared 510(K)
- K173693Orbitum Bone Staple Implant, X and VI2Cleared 510(K)
- K172205ExoToe Staple2Cleared 510(K)
- K172052Arthrex DynaNite Nitinol Staple2Cleared 510(K)
- K172405SNIPER STAPLE SYSTEM, NON-STERILE2Cleared 510(K)
- K171473Compressyn™ Staple2Cleared 510(K)
- K170923JAWS(TM) Nitinol Staple System2Cleared 510(K)
- K163226EPIC Extremely Small Staple2Cleared 510(K)
- K162354Sniper Staple System2Cleared 510(K)
- K162321EasyClip Xpress2Cleared 510(K)
- K163440Stealth Staple System2Cleared 510(K)
- K161587Memodyn Staple2Cleared 510(K)
- K161426NeoSpan Compression Staple Impant w/instruments2Cleared 510(K)
- K160813EasyStep2Cleared 510(K)
- K153622First Ray Internal Bone Staple System2Cleared 510(K)
- K153770OS2(R)-VP Varisation Staple2Cleared 510(K)
- K153395OS2-C Compression Staple2Cleared 510(K)
- K153129dynaMX Tabbed Staple2Cleared 510(K)
- K151762PediatrOS RigidTack/FlexTack2Cleared 510(K)
- K151615TiTHON Staple with OsseoTi Technology2Cleared 510(K)
- K151160Arcus Staple System2Cleared 510(K)
- K143622dynaMX Compression Staple2Cleared 510(K)
- K150125Elite Nitinol Fixation System2Cleared 510(K)
- K143323OS2-V Varisation Staple2Cleared 510(K)
- K143037SnapShot Fixation System2Cleared 510(K)
- K142111ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE2Cleared 510(K)
- K141263TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS2Cleared 510(K)
- K142292Speed, Speed Shift, Speed Titan, Speed Arc2Cleared 510(K)
- K142727CrossCLIP Implant System2Cleared 510(K)
- K142148ORTHOHELIX STAPLE SYSTEM2Cleared 510(K)
- K141550INSTAFIX SHAPE MEMORY FIXATION SYSTEM2Cleared 510(K)
- K140358COMPRESSYN STAPLE2Cleared 510(K)
- K133270SPEED ARC2Cleared 510(K)
- K133844SPEED TRIAD2Cleared 510(K)
- K133780SPEED XL2Cleared 510(K)
- K133523STAPIX SUPERELASTIC IMPLANT BONE STAPLES2Cleared 510(K)
- K132875COMPRESSYN STAPLE2Cleared 510(K)
- K131061RESTORE BUNION CORRECTION SYSTEM2Cleared 510(K)
- K130832ORTHOHELIX STAPLE SYSTEM2Cleared 510(K)
- K124045FUSEFORCE IMPLANT SYSTEM2Cleared 510(K)
- K124022SPEED SHIFT2Cleared 510(K)
- K123926METASURG NITINOL STAPLE IMPLANT2Cleared 510(K)
- K122113MEMORY METAL STAPLES, EASYCLIP2Cleared 510(K)
- K122871COMPRESSYN STAPLE2Cleared 510(K)
- K123363SUPER STAPLE(TM) CLASSIC2Cleared 510(K)
- K112837VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)2Cleared 510(K)
- K102387MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES2Cleared 510(K)
- K102143SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM2Cleared 510(K)
- K102107OSSTAPLE CHILL2Cleared 510(K)
- K082215OSTEORAPTOR SUTURE ANCHOR2Cleared 510(K)
- K081172COMPOSITE HITCH SUTURE ANCHOR2Cleared 510(K)
- K081098ENDOBUTTON CONTINUOUS LOOP (CL)2Cleared 510(K)
- K073281CAIS STAPLE2Cleared 510(K)
- K080111ARTHREX COMPRESSION STAPLE2Cleared 510(K)
- K072298BIOPRO MEMORY STAPLE, MODELS 18062-180732Cleared 510(K)
- K071477REVERTO 55 AND 37 SHAPE MEMORY STAPLES2Cleared 510(K)
- K071637INTRINSIC THERAPEUTICS FIXATION STAPLE2Cleared 510(K)
- K071479SBI STAFIX2Cleared 510(K)
- K071257MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD2Cleared 510(K)
- K070688NEXFIX COMPRESSION STAPLE2Cleared 510(K)
- K070031MEMOMETAL MEMORY STAPLES2Cleared 510(K)
- K070033MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-102Cleared 510(K)
- K063273PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR2Cleared 510(K)
- K062734ADJUST-RIGHT FIXATION DEVICES2Cleared 510(K)
- K061776ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE2Cleared 510(K)
- K062170BIOKNOTLESS AND LUPINE PLUS ANCHORS2Cleared 510(K)
- K061798BIOPRO MEMORY STAPLE2Cleared 510(K)
- K0618012.8 & 3.5MM LACTOSCREW SUTURE ANCHORS2Cleared 510(K)
- K061657HITCH LACTOSORB SUTURE ANCHOR2Cleared 510(K)
- K061389ALLTHREAD LACTOSORB SUTURE ANCHOR2Cleared 510(K)
- K060970AXYALOOP NONABSORBABLE BONE ANCHOR2Cleared 510(K)
- K061594LARGE UNI-CLIP STAPLE2Cleared 510(K)
- K060746MEMORY STAPLE2Cleared 510(K)
- K060553RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE2Cleared 510(K)
- K060014INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS2Cleared 510(K)
- K052631SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)2Cleared 510(K)
- K051989GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE2Cleared 510(K)
- K051408INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS2Cleared 510(K)
- K043059COMPRESSION STAPLE AND SIMPLE STAPLE2Cleared 510(K)
- K041988ARTHROTEK MENISCAL HYBRID DEVICE2Cleared 510(K)
- K041117PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 2127322Cleared 510(K)
- K041115GII QUICKANCHOR PLUS2Cleared 510(K)
- K041116SUPER QUICKANCHOR PLUS2Cleared 510(K)
- K041064BIOKNOTLESS RC ANCHOR2Cleared 510(K)
- K041065PANALOK RC LOOP ANCHOR2Cleared 510(K)
- K031127ORTHOPEDIC WIRE2Cleared 510(K)
- K023388MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM2Cleared 510(K)
- K021953MITEK PDS/PGA STAPLE2Cleared 510(K)
- K023417SURETAC III, MODELS 7209900, 72099012Cleared 510(K)
- K023203OSSTAPLE2Cleared 510(K)
- K020948SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II2Cleared 510(K)
- K012081DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM2Cleared 510(K)
- K011716THE UNI-CLIP STAPLE2Cleared 510(K)
- K010051POLY-TAPES WITH THE FASTLOK FIXATION DEVICE2Cleared 510(K)
- K002695MEMODYN STAPLE2Cleared 510(K)
- K003033SCAPHIX, STAPLE, FIXATION, BONE2Cleared 510(K)
- K001354MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM2Cleared 510(K)
- K000797OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-012Cleared 510(K)
- K993714MEMOGRAPH STAPLE, WARM SYSTEM2Cleared 510(K)
- K991962EIS DYNAMIC MEMORY STAPLES SYSTEM2Cleared 510(K)
- K991566SOLUSTAPLE2Cleared 510(K)
- K991482UNI-CLIP STAPLE2Cleared 510(K)
- K982996POLYMER OBL SB ANCHOR / SUTURE COMBINATION2Cleared 510(K)
- K982420MITEK MICRO ANCHOR2Cleared 510(K)
- K981798LACTOSORB POP RIVET2Cleared 510(K)
- K964226MEMORY STAPLE (20 SIZES AVAILABLE)2Cleared 510(K)
- K965175HOWMEDICA MAINSTAY ANCHOR2Cleared 510(K)
- K962793MITEK MICRO ANCHOR2Cleared 510(K)
- K962705MLI MODULAR STAPLE2Cleared 510(K)
- K961578SUTURE ANCHOR2Cleared 510(K)
- K961585SURGICAL DYNAMICS POP RIVET2Cleared 510(K)
- K961555ACUFEX TAG BIOABSORBABLE ANCHORS2Cleared 510(K)
- K954443LACTOSORB SUTURE ANCHOR2Cleared 510(K)
- K950272PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K953276ACUFEX TAG DELIVERY SYSTEM2Cleared 510(K)
- K953531HOWMEDICA MAINSTAY ANCHOR2Cleared 510(K)
- K953764LMT BONE ANCHOR2Cleared 510(K)
- K942889SB ANCHOR2Cleared 510(K)
- K952348OGDEN ANCHOR2Cleared 510(K)
- K941772CRADLE FIXATION DEVICE2Cleared 510(K)
- K951658LACTOSORB POP RIVET2Cleared 510(K)
- K943950ETHICON NONABSORBABLE SUTURE ANCHOR2Cleared 510(K)
- K950070MITEK TOGGLE ANCHOR(TM)2Cleared 510(K)
- K946346ACUFEX TAG(R) BIOABSORBABLE ANCHORS2Cleared 510(K)
- K944936MITEK G III ANCHOR, MITEK LS ANCHOR2Cleared 510(K)
- K943548BIOABSORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K945203MITEK THRADED ANCHOR (MTA)2Cleared 510(K)
- K941029OGDEN ANCHOR-SMALL (TENTATIVE)2Cleared 510(K)
- K934867ACUFEX TAG ANCHOR2Cleared 510(K)
- K943492ARTHREX STAPLES2Cleared 510(K)
- K935065OGDEN ANCHOR ADDITIONAL APPLICATIONS2Cleared 510(K)
- K942787BONE ANCHOR2Cleared 510(K)
- K935321INNOVASIVE SUTURE BONE FASTENER WITH SUTURE2Cleared 510(K)
- K932041XANCHOR SUTURE ATTACHMENT DEVICE2Cleared 510(K)
- K931782MITEK GIII ANCHOR2Cleared 510(K)
- K935167OGDEN ANCHOR (MODIFICATION)2Cleared 510(K)
- K931519ACUFEX SURETAC2Cleared 510(K)
- K931253QUICKANCHOR II2Cleared 510(K)
- K932925BONE ANCHOR FOR SOFT TISSUE ATTACHMENT2Cleared 510(K)
- K930967BAUMER STAPLES2Cleared 510(K)
- K930892MITEK MINI ANCHOR, MODIFICATION2Cleared 510(K)
- K930893MITEK SUPER QUICKANCHOR, MODIFICATION2Cleared 510(K)
- K926384STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE2Cleared 510(K)
- K926270MITEK LIGAMENT ANCHOR2Cleared 510(K)
- K930538ACUFEX SURETAC(R) PAC2Cleared 510(K)
- K924034MINVASIVE SUTURE BONE FASTENER2Cleared 510(K)
- K924367OGDEN ANCHOR2Cleared 510(K)
- K911293ACUFEX(R) TAG(TM)2Cleared 510(K)
- K931182VESITEC DRILL GUIDE2Cleared 510(K)
- K924941CONCEPT 4MM CANCELLOUS SCREW WITH EYELET2Cleared 510(K)
- K926037HARPOON SUTURE ANCHOR2Cleared 510(K)
- K924665QUICKANCHOR2Cleared 510(K)
- K915889MITEK BONE ANCHOR, MODIFICATION2Cleared 510(K)
- K921873QUICKANCHOR, MODIFICATION2Cleared 510(K)
- K920213MITEK ANCHOR, MITEK ANCHOR II2Cleared 510(K)
- K911837SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE2Cleared 510(K)
- K913461FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM2Cleared 510(K)
- K911445FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM2Cleared 510(K)
- K911026STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION2Cleared 510(K)
- K911031THE TRAMOND PIN2Cleared 510(K)
- K911020LIGAMENTOPLASTIC STAPLE OF L'UNION2Cleared 510(K)
- K910723BIODEGRADABLE SURGICAL STAPLE2Cleared 510(K)
- K905112SNAP-PAK (TM)2Cleared 510(K)
- K904553BONE STAPLE(S)2Cleared 510(K)
- K905364ROUND STAPLE2Cleared 510(K)
- K905363FIXATION STAPLE2Cleared 510(K)
- K905362BARBED SQUARE STAPLE2Cleared 510(K)
- K904340FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM2Cleared 510(K)
- K903022FIXATION STAPLE2Cleared 510(K)
- K903271ROUND STAPLE2Cleared 510(K)
- K903273BARBED SQUARE STAPLE2Cleared 510(K)
- K902751MITEK ANCHOR II2Cleared 510(K)
- K896471TENSTAPLE ORTHOPEDIC STAPLING SYSTEM2Cleared 510(K)
- K902567STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES2Cleared 510(K)
- K895117HTO COMPRESSING STAPLE2Cleared 510(K)
- K897155MITEK ANCHOR(TM)2Cleared 510(K)
- K893203BONE SCREW2Cleared 510(K)
- K892126MITEK ANCHOR2Cleared 510(K)
- K894929STAPLE FIXATION SYSTEM2Cleared 510(K)
- K890962ORTHOPAEDIC STAPLES2Cleared 510(K)
- K874914ORTHOMET ORTHOPEDIC STAPLES2Cleared 510(K)
- K873507LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM2Cleared 510(K)
- K861137ORTHOMED ORTHOPAEDIC FIXATION STAPLES2Cleared 510(K)
- K853704LINK DYNAMIC STAPLE2Cleared 510(K)
- K854445KIRSCHNER BONE FIXATION FASTENER SYSTEM2Cleared 510(K)
- K853267DAY STAPLE2Cleared 510(K)
- K840566BONE STAPLING FIXATION SYS2Cleared 510(K)
- K832884FIXATION STAPLE DRIVER/EXTRACTOR2Cleared 510(K)
- K830455STAPLES DESIGNED FOR ARTHROSCOPIC SURG2Cleared 510(K)
- K822943ELLISON VITALLIUM FIXATION STAPLE SYS2Cleared 510(K)
- K813567TECHMEDIA BONE STAPLE2Cleared 510(K)
- K811500COLBALT ALLOY ORTHOPAEDIC WIRE2Cleared 510(K)
- K792204HOWMEDICA COMPRESSION STAPLE SYSTEM2Cleared 510(K)
- JDSNail, Fixation, Bone2Product Code
- JDTCap, Bone1Product Code
- JDWPin, Fixation, Threaded2Product Code
- JECComponent, Traction, Invasive2Product Code
- 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
ORTHOHELIX STAPLE SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K130832
- 510(k) Type
- Traditional
- Applicant
- ORTHOHELIX SURGICAL DESIGNS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/15/2013
- Days to Decision
- 142 days
- Submission Type
- Summary