meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
29
Latest Decision
1995-08-21

Clearances · page 143 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K951657 VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S) Acromed Corp. MNH Class II 1995-08-21
K951626 SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM Synthes (Usa) MNH Class II 1995-08-21
K952348 OGDEN ANCHOR American Medical Electronics, Inc. JDR Class II 1995-08-21
K950009 POWERGRIP(TM) COMPRESSION FIXATION DEVICE Synvasive Technology, Inc. JDW Class II 1995-08-18
K934060 HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE Howmedica Corp. LPH Class II 1995-08-18
K936292 PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS Howmedica Corp. LPH Class II 1995-08-18
K952740 DEPUY DURALOC 400 ACETABULAR CUP Depuy, Inc. LPH Class II 1995-08-18
K952296 SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW Synthes (Usa) HWC Class II 1995-08-18
K950093 AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES Smith & Nephew Richards, Inc. HRX Class II 1995-08-15
K936307 DYNA-LOK ANTERIOR PLATING SYSTEM Danek Group, Inc. MNH Class II 1995-08-14
K941862 INTEQ TFCC REPAIR SYSTEM Linvatec Corp. HRX Class II 1995-08-14
K933882 OSTEONICS PS HEMI-HIP STEM SERIES Osteonics Corp. LPH Class II 1995-08-14
K944321 S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II Joint Medical Products Corp. JWH Class II 1995-08-14
K943778 OSTEONICS RESTORATION CEMENTED HIP STEM SERIES Osteonics Corp. KWL Class II 1995-08-14
K951116 ACROMED PEDICLE SCREW Acromed Corp. MNH Class II 1995-08-11
K951740 INTRAMEDULARY FIXATION ROD Acu Med, Inc. HSB Class II 1995-08-11
K950074 WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM Wrightmedicaltechnologyinc MNH Class II 1995-08-11
K951956 OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES Osteonics Corp. JWH Class II 1995-08-11
K953387 ECTRA LIGAMENT RELEASE SYSTEM Smith & Nephew Dyonics, Inc. HRX Class II 1995-08-09
K951471 STRICKLAND TRAPEZIAL IMPLANT Wrightmedicaltechnologyinc KYI Class II 1995-08-09
K951291 OSTEONICS RESTORATION MONOLITHIC HIP STEM Osteonics Corp. MEH Class II 1995-08-09
K936008 DURACON BASEPLATES Howmedica Corp. JWH Class II 1995-08-09
K953510 HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS Encore Orthopedics, Inc. KWY Class II 1995-08-09
K953169 STELKAST ALL POLYETHYLENE ACETABULAR CUP Stelkast Company LZO Class II 1995-08-08
K946088 GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM Smith & Nephew Richards, Inc. JWH Class II 1995-08-08
K946348 TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) Sofamor Danek USA,Inc. MNH Class II 1995-08-07
K941772 CRADLE FIXATION DEVICE Neoligaments, Ltd. JDR Class II 1995-08-07
K951741 REPLICA TOTAL HIP SYSTEM Osteo-Technology Intl., Inc. LPH Class II 1995-08-07
K952471 BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD Bioscience, Inc. MAI Class II 1995-08-07
K951268 SPINE-TECH MODIFIED LAPAROSCOPIC SPINAL FUSION INSTRUMENT SYSTEM Spine-Tech, Inc. HRX Class II 1995-07-31
K952272 TI. ALLOY 2.0 MM CORTEX SCREW Synthes (Usa) HWC Class II 1995-07-31
K943249 BIOABSORBABLE INTERFERENCE SCREW Instrument Makar, Inc. MAI Class II 1995-07-31
K952640 CANNULATED PLUS HIP SCREW Wrightmedicaltechnologyinc JDW Class II 1995-07-31
K951308 5.8MM DIAMETER ANCHOR SCREW Advanced Spine Fixation Systems, Inc. MNH Class II 1995-07-26
K951624 ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM Argus Medical Co., Inc. HRX Class II 1995-07-26
K951172 TITANIUM LOW PROFILE CROSS BAR Advanced Spine Fixation Systems, Inc. MNH Class II 1995-07-25
K951658 LACTOSORB POP RIVET Poly-Medics,Inc. JDR Class II 1995-07-25
K951389 REUNION BONE SCREW SYSTEM Smith & Nephew Richards, Inc. HWC Class II 1995-07-24
K952397 VITALOCK SOLID BACKED ACETABULAR SHELL Howmedica Corp. LPH Class II 1995-07-21
K950695 DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION Depuy Motech MNH Class II 1995-07-21
K945700 SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM Synthes (Usa) KWQ Class II 1995-07-20
K951656 NEXMED CANCELLOUS BONE SCREWS Nexmed, Inc. HWC Class II 1995-07-18
K934857 HSS FEMORAL COMPONENTS Hospital For Special Surgery JDI Class II 1995-07-18
K952297 FOUNDATION TEXTURED STEM Encore Orthopedics, Inc. LWJ Class II 1995-07-17
K951904 SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] Synthes (Usa) JDO Class II 1995-07-17
K950178 PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET Pharma-Plast Intl. A/S LZE Class I 1995-07-17
K952191 FORGED CEMENTED STEM Encore Orthopedics, Inc. JDI Class II 1995-07-17
K951027 DEPUY AMK CO-CR FINNED TIBIAL TRAY Depuy, Inc. JWH Class II 1995-07-17
K951941 CITATION MULTIPLE USE DELTA SCOPE Citation Medical Corp. HRX Class II 1995-07-14
K951843 REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT Future Medical Systems, Inc. HRX Class II 1995-07-14
K940631 CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM Cross Medical Products, Inc. MNH Class II 1995-07-13
K952534 TENTATIVELY POLARUS EX ROD Acu-Med, Inc. HSB Class II 1995-07-13
K951809 GLIDING NAIL Encore Orthopedics, Inc. KTT Class II 1995-07-13
K951844 BIOMECHANIC LOW-PROFILE CABLE SYSTEM Biomechanic, Inc. JDQ Class II 1995-07-13
K944507 METALLIC RADIAL HEAD IMPLANTS Wrightmedicaltechnologyinc KWI Class II 1995-07-13
K943855 BONE FIXATION NAIL Acu Med, Inc. JDS Class II 1995-07-12
K942432 J.B.S. CERVICAL SPINE SYSTEM J.B.S., S.A. KWP Class II 1995-07-11
K942263 MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM Zimmer, Inc. HSX Class II 1995-07-11
K946150 CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK) Zimmer, Inc. JWH Class II 1995-07-11
K946347 ABSORBABLE ACETABULAR SCREW Zimmer, Inc. HWC Class II 1995-07-11
K945525 ANSPACH SUTURE ANCHOR The Anspach Effort, Inc. HWC Class II 1995-07-11
K935263 FOUNDATION POROUS STEM Encore Orthopedics, Inc. JDI Class II 1995-07-11
K950875 OGDEN ANCHOR American Medical Electronics, Inc. HWC Class II 1995-07-11
K951655 DURACON RECESSED PATELLA Howmedica Corp. JWH Class II 1995-07-11
K950833 DEPUY SET SCREW Depuy, Inc. HWC Class II 1995-07-10
K946236 PROFIX CONFORMING PLUS TIBIAL INSERT Smith & Nephew Richards, Inc. KWH Class II 1995-07-06
K943856 FIXATION PINS/WIRES Acu Med, Inc. HTY Class II 1995-07-06
K941612 F-230 POROUS FEMORAL HIP STEM (CEMENTLESS) Implex Corp. LPH Class II 1995-07-06
K951673 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Acu Med, Inc. HSB Class II 1995-07-06
K932350 ORTHOPEDIC SCREW FIXATION Osteomed Corp. HWC Class II 1995-07-05
K932352 ORTHOPEDIC BONE PLATE Osteomed Corp. HRS Class II 1995-07-05
K943986 LINK ENDO MODEL REVISION CUP Turnkey Intergration USA, Inc. HRS Class II 1995-07-05
K951233 LMT BONE ANCHOR Li Medical Technologies, Inc. HWC Class II 1995-07-03
K951545 OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS American Medical Electronics, Inc. HWC Class II 1995-07-03
K952418 V40 ZIRCONIA FEMORAL HEADS Howmedica Corp. LZO Class II 1995-07-03
K951472 LMT BONE ANCHOR Li Medical Technologies, Inc. HWC Class II 1995-07-03
K951493 OGDEN ANCHOR American Medical Electronics, Inc. HWC Class II 1995-07-03
K943806 HARPOON SUTURE ANCHORS Biomet, Inc. HWC Class II 1995-07-03
K952088 ZIRCONIA ARTICUL/EZE FEMORAL BALLS Depuy, Inc. LZO Class II 1995-06-30
K952461 ENDO PROSTHESIS FEMORAL HEAD Stelkast Company JDI Class II 1995-06-30
K950704 K4 BONE SCREW SYSTEM Kinetikos Medical, Inc. HWC Class II 1995-06-30
K950054 ENDO-BEND(TM) SHAVER Paladin Medical, Inc. HRX Class II 1995-06-29
K951303 SFC Medpac HWC Class II 1995-06-27
K945390 CITATION DELTA SCOPE Citation Medical Corp. HRX Class II 1995-06-23
K950652 OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS Osteotech, Inc. HWC Class II 1995-06-22
K944737 ISOLA SPINE SYSTEM Acromed Corp. MNH Class II 1995-06-22
K950697 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION Depuy Motech MNH Class II 1995-06-22
K951415 LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW Howmedica Corp. HRS Class II 1995-06-22
K945687 ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW Smith and Nephew Donjoy, Inc. HWC Class II 1995-06-22
K945781 WEBB-MORLEY SPINE SYSTEM Electro-Biology, Inc. KWP Class II 1995-06-22
K951726 S-ROM ZTP UHMWPE ACETABULAR CUP Joint Medical Products Corp. JDI Class II 1995-06-21
K951357 EBI SMALL EXTERNAL FIXATOR (S/E/F/) Electro-Biology, Inc. KTT Class II 1995-06-21
K930353 SIMMONS PLATING SYSTEM BOLT AND SCREW Smith & Nephew, Inc. MNH Class II 1995-06-20
K951356 VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED Biologically Oriented Prostheses LPH Class II 1995-06-19
K951304 SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER Synthes (Usa) HWC Class II 1995-06-16
K950521 OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT Osteonics Corp. KWS Class II 1995-06-16
K951114 SYSTEM 12 P1 26MM ACETABULAR INSERT Howmedica Corp. LPH Class II 1995-06-16
K951115 HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS Howmedica Corp. LPH Class II 1995-06-16
K946290 CITATION POWER TOOL Citation Medical Corp. HRX Class II 1995-06-15
K950418 ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) Wrightmedicaltechnologyinc JDI Class II 1995-06-15

17,115 clearances in the Orthopedic panel. Data: openFDA.