meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
23
Latest Decision
1994-09-07

Clearances · page 147 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K932210 ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT Dow Corning Wright JWH Class II 1994-09-07
K941691 REVO ROTATOR CUFF REPAIR SYSTEM Linvatec Corp. HRX Class II 1994-09-06
K934620 ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE Wrightmedicaltechnologyinc JWH Class II 1994-09-01
K933290 ORTHOLOC ADVANTIM Wrightmedicaltechnologyinc JWH Class II 1994-09-01
K930275 PRECISION OSTEOLOCK ACETABULAR COMPONENT Howmedica Corp. JDI Class II 1994-09-01
K930009 STRYKER 2S SPINAL SYSTEM Stryker Corp. KWP Class II 1994-09-01
K931155 STAPLE, FIXATION BONE; SCREW FIXATION BONE Roseburg SA HWC Class II 1994-09-01
K932017 TECHMEDICA CONTINUUM HIP WITH HA COATING Techmedica, Inc. MEH Class II 1994-09-01
K941711 HYPERFLEX FLEXIBLE GUIDEWIRES Linvatec Corp. LXH Class I 1994-08-26
K933289 THICK TIBIAL INSERT Wrightmedicaltechnologyinc JWH Class II 1994-08-25
K931131 THE RICHARDS WRIST Smith & Nephew Richards, Inc. JWJ Class II 1994-08-19
K935193 CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM U.S. Medical Products, Inc. LZO Class II 1994-08-18
K936269 CASPAR TITANIUM ALLOY BONE SCREWS Aesculap, Inc. KWQ Class II 1994-08-15
K932041 XANCHOR SUTURE ATTACHMENT DEVICE Orthopaedic Biosystems JDR Class II 1994-08-12
K940234 CARPAL TUNNEL SYSTEM Richard Wolf Medical Instruments Corp. HRX Class II 1994-08-11
K941605 STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH Stryker Corp. LXH Class I 1994-08-05
K933843 LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED Kirschner Medical Corp. JWH Class II 1994-08-05
K931653 SPINE-TECH CERVICAL FIXATION SYSTEM Spinal Technologies KWQ Class II 1994-08-04
K932721 ARTHROTEK SET SCREW Biomet, Inc. HWC Class II 1994-08-01
K936233 PELVIC RADIUS PLATE Smith & Nephew Richards, Inc. HRS Class II 1994-08-01
K934059 DALL MILES SYSTEM GROOVED BUTTON Howmedica Corp. JDQ Class II 1994-08-01
K935875 OSTEONICS SCREWLESS ACETABULAR COMPONENTS Osteonics Corp. LPH Class II 1994-07-29
K932425 FOUNDATION MODULAR TIBIAL BASEPLATE Encore Orthopedics, Inc. JWH Class II 1994-07-22
K931782 MITEK GIII ANCHOR Mitek Surgical Products, Inc. JDR Class II 1994-07-22
K935696 ETEX HA HIP REPLACEMENT SYSTEM Etex Corp. MEH Class II 1994-07-22
K932246 FOUNDATION METAL-BACKED PATELLA Encore Orthopedics, Inc. JWH Class II 1994-07-22
K934729 UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED Implantology Corp. MEH Class II 1994-07-22
K933948 ACUFEX ENDOBUTTON SYSTEM Acufex Microsurgical, Inc. MAI Class II 1994-07-21
K934159 IOI COCR UNIPOLAR PROSTHESIS Intermedics Orthopedics KWY Class II 1994-07-21
K925098 BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE Bioscience, Inc. HTY Class II 1994-07-19
K935951 KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM Kirschner Medical Corp. JDI Class II 1994-07-18
K931651 NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW Intermedics Orthopedics JWH Class II 1994-07-18
K934589 KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED Kirschner Medical Corp. JWH Class II 1994-07-13
K935990 F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM Implex Corp. MEH Class II 1994-07-13
K935206 KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION Kirschner Medical Corp. JDI Class II 1994-07-13
K935453 CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM U.S. Medical Products, Inc. MEH Class II 1994-07-13
K933881 DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM Depuy, Inc. KWP Class II 1994-07-12
K940207 TITANIUM ALLOY BONE SCREWS Aesculap, Inc. HWC Class II 1994-07-12
K941942 SOLUTION HIP Depuy, Inc. LZO Class II 1994-07-12
K935167 OGDEN ANCHOR (MODIFICATION) American Medical Electronics, Inc. JDR Class II 1994-07-12
K941847 5/8 POROCOAT AML HIP POROCOAT POROUS COATING Depuy, Inc. LZO Class II 1994-07-12
K936280 GALILEO ARTHROSCOPES Galileo Electro-Optics Corp. HRX Class II 1994-07-12
K934457 STABILITY HIP STEM WITH POROCOAT Depuy, Inc. LZO Class II 1994-07-06
K932911 ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT Dow Corning Wright JWH Class II 1994-06-30
K933340 OSTEO INTERLOCKING-COMPRESSION NAIL Osteo AG HSB Class II 1994-06-30
K930515 ALPHA SPINAL SYSTEM Alphatec Mfg., Inc. KWP Class II 1994-06-29
K940222 SMITH AND NEPHEW SPINE DEFLECTING FORCEPS Smith & Nephew, Inc. HRX Class II 1994-06-29
K940554 TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS Tnco, Inc. HRX Class II 1994-06-29
K930657 D-C-S SYSTEM Pina-Vertriebs KWP Class II 1994-06-29
K931836 ACUFEX SMOOTH AND THREADED PINS Acufex Microsurgical, Inc. HTY Class II 1994-06-28
K932099 ACUMED FLEXIBLE CANNULA Acu Med, Inc. HRX Class II 1994-06-28
K932090 ACUFEX DISPOSABLE MENISCAL CANNULA Acufex Microsurgical, Inc. HRX Class II 1994-06-28
K925225 THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK Baltimore Therapeutic Equipment Co. KQX Class I 1994-06-27
K934582 GDLH VARIABLE ANGLE CONNECTOR Danek Group, Inc. KWP Class II 1994-06-21
K931253 QUICKANCHOR II Mitek Surgical Products, Inc. JDR Class II 1994-06-16
K931519 ACUFEX SURETAC Acufex Microsurgical, Inc. JDR Class II 1994-06-16
K933968 ACE PELVIC STABILIZER Ace Medical Co. JEC Class II 1994-06-16
K935185 MORPHOMETRIC TOTAL HIP PROSTHESIS Landos, Inc. LZO Class II 1994-06-16
K930480 VARIABLE ANGULAR HOLD BONE PLATE SYSTEM Smith & Nephew Richards, Inc. HRS Class II 1994-06-15
K932935 TITAN DYSPLASIC TOTAL HIP PROSTHESIS Landos, Inc. LZO Class II 1994-06-15
K936214 CS-PLUS STEM Encore Orthopedics, Inc. JDI Class II 1994-06-15
K931617 EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT Exactech, Inc. LZO Class II 1994-06-14
K936132 EXETER ALL PLASTIC ACETABULAR COMPONENT Howmedica, Inc. JDI Class II 1994-06-14
K931655 P.F.C. BIPOLAR HIP SYSTEM Johnson & Johnson Orthopaedics, Inc. KWY Class II 1994-06-09
K932481 SL-PLUS AND SLR-PLUS Encore Orthopedics, Inc. JDI Class II 1994-06-08
K931690 SPOON PLATE Onyx Medical Corp. HRS Class II 1994-06-07
K933281 S.O.S. PROXIMAL FEMUR Wrightmedicaltechnologyinc JDI Class II 1994-06-07
K933867 UNIVERSAL INSET PATELLA Johnson & Johnson Orthopaedics, Inc. JWH Class II 1994-06-06
K935484 PROVIDENT HIP SYSTEM Stelkast Company LPH Class II 1994-06-06
K936043 FOUNDATION POROUS ACETABULAR COMPONENT Encore Orthopedics, Inc. JDI Class II 1994-06-03
K935262 P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA Johnson & Johnson Orthopaedics, Inc. JWH Class II 1994-06-03
K940090 ARTHROSCOPE Richard Wolf Medical Instruments Corp. HRX Class II 1994-06-03
K934412 COATED ZT PROXIMAL SLEEVE Joint Medical Products Corp. LPH Class II 1994-06-03
K934860 TI-FRAME Johnson & Johnson Professionals, Inc. KWP Class II 1994-06-03
K934354 LACEY ALL POLYETHYLENE TIBIAL COMPONENT Dow Corning Wright JWH Class II 1994-06-03
K934007 SOFAMOR ORFIL SPINE FIXATION SYSTEM Sofamor Co. KWP Class II 1994-06-02
K932222 SLT FEMORAL HEAD Dow Corning Wright LZO Class II 1994-05-27
K940515 POLY BLADES Linvatec Corp. HRX Class II 1994-05-26
K941269 GORE SMOOTHER II AND GORE BPTB W. L. Gore & Associates, Inc. HRX Class II 1994-05-19
K931676 S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG Joint Medical Products Corp. JDL Class III 1994-05-18
K936213 ARTHROSCOPES AND ACCESSORIES Micro-Medical Devices, Inc. HRX Class II 1994-05-18
K933499 CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM U.S. Medical Products, Inc. LZO Class II 1994-05-18
K934694 KIRSCHNER ZIRCONIA FEMORAL HEAD Kirschner Medical Corp. LZO Class II 1994-05-18
K933719 BIOSCREW ABSORBABLE INTERFERENCE SCREW Linvatec Corp. HWC Class II 1994-05-17
K941364 ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS Acufex Microsurgical, Inc. HRX Class II 1994-05-16
K933567 EUROFORM TOTAL HIP PROSTHESIS Landos, Inc. LZO Class II 1994-05-16
K940985 ACUFEX(R) ARTHROPLASTY INSTRUMENTS Acufex Microsurgical, Inc. HRX Class II 1994-05-16
K940981 ACUFEX LINEAR/ROTARY INSTRUMENTS Acufex Microsurgical, Inc. HRX Class II 1994-05-16
K933102 HOWMEDICA ACETABULAR SHELL W/SCREW HOLES Howmedica Corp. LPH Class II 1994-05-16
K931697 FIXATION PIN Orthologic Corp. HTY Class II 1994-05-12
K932924 IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED Implex Corp. LPH Class II 1994-05-12
K931114 SELECT(R) SHOULDER ALL-POLY GLENOID Intermedics Orthopedics KWT Class II 1994-05-09
K940481 ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM Acufex Microsurgical, Inc. HRX Class II 1994-05-06
K932755 REFLECTION ACETABULAR COMPONENT Smith & Nephew Richards, Inc. LPH Class II 1994-05-06
K931194 CO-CR ANSWER FEMORAL COMPONENT Biomet, Inc. JDG Class II 1994-05-05
K931684 EPIPHYSIS PLATE Onyx Medical Corp. HRS Class II 1994-05-04
K933205 TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON Danek Medical, Inc. KWP Class II 1994-05-04
K931680 CANNULATED CANCELLOUS SCREW Onyx Medical Corp. HWC Class II 1994-05-04
K931538 AMSET(TM) CANNULATED BONE SCREW Advanced Med/Surg, Inc. HWC Class II 1994-05-04
K931692 T-PLATE Onyx Medical Corp. HRS Class II 1994-05-04

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