meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
27
Latest Decision
1993-05-12

Clearances · page 151 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K923869 CODMAN SOF'WIRE TITANIUM CABLE SYSTEM Codman & Shurtleff, Inc. JDQ Class II 1993-05-12
K923965 NK GRASP SENSOR, MODEL GA002 Nk Biotechnical Engineering Co. LBB Class II 1993-05-12
K922861 BIOMETRIC SCREW FIXATION CUP Osteo Technology, Inc. JDL Class III 1993-05-12
K924455 SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER Synthes (Usa) HTN Class II 1993-05-12
K925348 IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM Implex Corp. JDI Class II 1993-05-12
K923964 NK GRASP SENSOR, MODEL GA001 Nk Biotechnical Engineering Co. LBB Class II 1993-05-12
K920969 HYDROXYLAPATITE INFINITY(R) Dow Corning Wright MEH Class II 1993-05-05
K925573 ACUFEX T-BAR Acufex Microsurgical, Inc. HRX Class II 1993-05-05
K920621 ACUFEX PASSING PINS AND SURGICAL WIRE Acufex Microsurgical, Inc. HWQ Class I 1993-05-05
K920929 POLY INSERT 20 DEGREE Dow Corning Wright JDL Class III 1993-05-05
K926037 HARPOON SUTURE ANCHOR Biomet, Inc. JDR Class II 1993-05-05
K915525 WHITESIDE ORTHOLOC(R) MODULAR REVISION FEMOR COMP Dow Corning Wright JWH Class II 1993-05-05
K920968 INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD Dow Corning Wright LZO Class II 1993-05-05
K923381 SOFT TISSUE EXPANDER Acufex Microsurgical, Inc. HWQ Class I 1993-05-05
K924099 UFC HIP STEM COMPONENT Implantology Corp. JDG Class II 1993-04-30
K915391 FPC HIP STEM COMPONENT Implantology Corp. JDG Class II 1993-04-30
K915787 STABILITY HIP STEM WITH POROCOAT Depuy, Inc. JDG Class II 1993-04-29
K925083 ENDOTRAK SYSTEM Instratek, Inc. HRX Class II 1993-04-27
K925695 OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD Osteonics Corp. LZO Class II 1993-04-20
K923911 INTRINSIC STEM Turnkey Intergration USA, Inc. LWJ Class II 1993-04-14
K925500 ALPHATEC 130 COMPRESSION HIP SCREW Alphatec Mfg., Inc. HRS Class II 1993-04-14
K915594 STABILITY HIP FEMORAL COMPONENT Depuy, Inc. JDI Class II 1993-04-14
K923275 RMHS MONOLITHIC FEMORAL COMPONENT Smith & Nephew Richards, Inc. JDI Class II 1993-04-08
K924144 ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR) Davol, Inc. HRX Class II 1993-04-08
K925577 DANEK TISSUE RESECTING SYSTEM Sofamor Danek Mfg., Inc. HRX Class II 1993-04-08
K926579 TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE Techmedica, Inc. HWC Class II 1993-04-06
K922847 PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. JDI Class II 1993-04-06
K911729 DANEKSCOPE AND ACCESSORIES Danek Medical, Inc. HRX Class II 1993-04-05
K921400 HIP JOINT PROTHESIS Smith & Nephew Richards, Inc. LPH Class II 1993-04-02
K924018 M3 LAG SCREW FIXATION SYSTEM Osteomed Corp. HWC Class II 1993-04-01
K926047 ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW Ace Orthopedic Manufacturing Co. HWC Class II 1993-03-31
K923443 NATURAL-KNEE ALL-POLY TIBIA Intermedics Orthopedics JWH Class II 1993-03-31
K923963 NK DIGI-GRIP SENSOR, MODEL DGR001 Nk Biotechnical Engineering Co. LBB Class II 1993-03-31
K926120 CONTOUR FEMORAL HIP STEM WITH POROCOAT Depuy, Inc. KWL Class II 1993-03-31
K926116 CODMAN SOFWIRE(TM) KIT Codman & Shurtleff, Inc. JDQ Class II 1993-03-30
K926231 DURACON UNICOMPARTMENTAL KNEE SYSTEM Howmedica Corp. HSX Class II 1993-03-30
K925812 TITANIUM SONGER CABLE SYSTEM Sofamor Danek Mfg., Inc. JDQ Class II 1993-03-24
K925127 ALTA CANCELLOUS BONE SCREW Howmedica Corp. KTT Class II 1993-03-22
K925901 KINEMAX(R) CONDYLAR TOTAL KNEE SYST FEMORAL SPACER Howmedica Corp. JWH Class II 1993-03-22
K923477 3.5MM UNIVERSAL COMPRESSION SCREW Howmedica Corp. HWC Class II 1993-03-19
K925301 OTI ORTHOPEDIC FASTENER SYSTEM Osteo Technology, Inc. HTY Class II 1993-03-16
K922682 AMERICANA HIP PROTHESIS Osteo Technology, Inc. JDG Class II 1993-03-16
K923573 DURACON METAL BACKED PATELLA Howmedica Corp. JWH Class II 1993-03-16
K924017 SYMBIOSIS DISPOSABLE ARTHROSCOPIC SURGICAL INST. Symbiosis Corp. HRX Class II 1993-03-16
K925996 ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES Arthrex, Inc. HRX Class II 1993-03-16
K926193 ARTHREX INSTRUMENTS (SHOULDER GP. 1) Arthrex, Inc. HRX Class II 1993-03-16
K926111 ARTHROSCOPIC KNEE INSTRUMENTS Arthrex, Inc. HRX Class II 1993-03-16
K926062 ARTHROSCOPIC KNEE INSTRUMENTS Arthrex, Inc. HRX Class II 1993-03-16
K922788 BIOACTION LOW PROFILE SCREW SYSTEM Orthopaedic Biosystems HWC Class II 1993-03-12
K924940 FEMORAL & TIBIAL AUGMENT BLOCK Joint Medical Products Corp. JWH Class II 1993-03-09
K925954 ARTHREX INSTRUMENTS (BASIC) Arthrex, Inc. HRX Class II 1993-03-04
K925995 ARTHREX INSTRUMENTS (KNEE, GP 3) Arthrex, Inc. HRX Class II 1993-03-04
K915798 PSK POSTERIOR STABILIZED TOATAL KNEE Implantology Corp. JWH Class II 1993-03-04
K925884 ARTHROSCOPIC RETRACTORS AND GRASPERS Arthrex, Inc. HRX Class II 1993-03-04
K925456 ARTHROSCOPIC INSTRUMENTS Arthrex, Inc. HRX Class II 1993-03-04
K925544 SEIDEL HUMERAL LOCKING NAIL & ADDITIONAL LENGTHS Howmedica Corp. HSB Class II 1993-03-04
K925814 ARTHREX INSTRUMENTS (BASIC) Arthrex, Inc. HRX Class II 1993-03-04
K923861 LUHR PAN FIXATION SYSTEM Howmedica Corp. HRS Class II 1993-03-04
K925458 ARTHREX RING CURETTE Arthrex, Inc. HRX Class II 1993-03-04
K925986 ARTHROSCOPIC ACL DRILL SYSTEM Arthrex, Inc. HRX Class II 1993-03-04
K925457 ARTHREX BAYONET KNIFE Arthrex, Inc. HRX Class II 1993-03-04
K922952 SONGER CABLE SYSTEM Pioneer Surgical Technology JDQ Class II 1993-02-23
K911058 TECHMEDICA CAD/CAM CUSTOM HIP Techmedica, Inc. JDI Class II 1993-02-23
K930028 CALMPS: BONE, MASTIN, LEWIN, BRAND Thomasville Medical Assoc. LXH Class I 1993-02-16
K925512 CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION Dow Corning Wright LZO Class II 1993-02-12
K922866 OTI BONE PLUG Osteo Technology, Inc. JDI Class II 1993-02-12
K922871 UNIFIT FEMORAL STEM Osteo Technology, Inc. JDI Class II 1993-02-12
K924323 THE UNIVERSAL BONE CEMENT RESISTOR Biodynamic Technologies, Inc. JDI Class II 1993-02-12
K922868 THOMPSON TYPE HIP PROTHESIS Osteo Technology, Inc. KWA Class III 1993-02-12
K922862 CHARNLEY TYPE HIP PROTHESIS Osteo Technology, Inc. JDI Class II 1993-02-12
K922860 AUSTIN-MOORE TYPE HIP PROSTHESIS Osteo Technology, Inc. JDI Class II 1993-02-12
K922864 MUELLER TYPE FEMORAL STEM Osteo Technology, Inc. JDI Class II 1993-02-12
K925372 OSTEONICS(R) 700 SERIES TOTAL KNEE MOD FEMOR COMP Osteonics Corp. JWH Class II 1993-02-12
K915584 CRK CONDYLAR RESURFACING TOTAL KNEE Implantology Corp. JWH Class II 1993-02-12
K922863 EUROSTEM HIP PROTHESIS SYSTEM Osteo Technology, Inc. JDI Class II 1993-02-12
K924379 ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM Johnson & Johnson Orthopaedics, Inc. KWL Class II 1993-02-12
K921338 ANSPACH MINI-PLATING SYSTEM The Anspach Effort, Inc. HRS Class II 1993-02-10
K925895 ETEX HIP REPLACEMENT SYSTEM Etex Co. JDI Class II 1993-02-09
K923277 FOUNDATION KNEE SYSTEM Encore Orthopedics, Inc. JWH Class II 1993-02-09
K915424 ARTHREX CANNULATED INTERFERENCE SCREW Arthrex, Inc. HWC Class II 1993-02-09
K923142 ARTHREX PLUS Arthrex, Inc. HRX Class II 1993-02-09
K922733 PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP Orthomet, Inc. JDI Class II 1993-02-09
K923525 NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR Surgical Dynamics, Inc. HRX Class II 1993-02-09
K925455 ARTHREX ATRAUMATIC MINI-GRASPER Arthrex, Inc. HRX Class II 1993-02-08
K922890 ARTHREX KNEE ARTHROSCOPIC SURGERY ACCESSORIES Arthrex, Inc. HRX Class II 1993-02-08
K925181 TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP Techmedica, Inc. JDL Class III 1993-02-05
K923597 SYNTHES TITANIUM UNREAMED FEMORAL NAIL Synthes (Usa) HSB Class II 1993-01-21
K920546 PARAGON POSTERIOR SPINAL SYSTEM Sofamor Danek Mfg., Inc. KWP Class II 1993-01-21
K923580 SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL Synthes (Usa) HSB Class II 1993-01-21
K914078 DEPUY HIP PROSTHESIS Depuy, Inc. JDI Class II 1993-01-07
K922645 LSF ANATOMIC CEMENTED HIP Osteo Technology, Inc. JDI Class II 1993-01-07
K921090 ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR Acromed Corp. KWP Class II 1992-12-31
K920392 ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION Acromed Corp. KWP Class II 1992-12-31
K925335 ACUFEX INTRA ARTICULAR MEASURING DEVICE Acufex Microsurgical, Inc. HTJ Class I 1992-12-29
K915190 PERFECTA TOTAL HIP SYSTEM, HA COATED Orthomet, Inc. MEH Class II 1992-12-24
K925437 ACUFEX CANNULATED BONE TUNNEL PLUGS Cufex Microsurgical, Inc. HRX Class II 1992-12-24
K922238 LEAPLAZA FRAME Spintech, Inc. KWP Class II 1992-12-23
K920802 ALVINE TOTAL ANKLE Depuy, Inc. HSN Class II 1992-12-17
K924085 RECONSTRUCTION PLATE SYSTEM Sofamor Danek Mfg., Inc. HRS Class II 1992-12-17
K923446 STERILE DYNA LOK ANTERIOR PLATING SYSTEM Sofamor Danek Mfg., Inc. KWQ Class II 1992-12-17

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