meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
37
Latest Decision
1989-10-11

Clearances · page 159 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K892640 PNEUMOTHORAX KIT, MOTIFICATION Arrow Intl., Inc. JDL Class III 1989-10-11
K893537 GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM Greenleaf Medical Systems, Inc. LBB Class II 1989-10-10
K894472 CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL Buckman Co., Inc. KWP Class II 1989-10-10
K892228 INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM Intermedics Orthopedics HRS Class II 1989-10-06
K892903 MITEK ANCHOR DRILL Mitek Surgical Products, Inc. HTW Class I 1989-10-06
K894334 SECOND GENERATION KNEE SYSTEM Orthomet, Inc. JWH Class II 1989-10-06
K892904 MITEK DRILL GUIDE Mitek Surgical Products, Inc. HXY Class I 1989-09-28
K894298 MODIFIED GEMINI ACETABULAR CUP Depuy, Inc. JDI Class II 1989-09-27
K893685 CERAMIC FEMORAL HEAD Dow Corning Wright LZO Class II 1989-09-26
K892126 MITEK ANCHOR Mitek Surgical Products, Inc. JDR Class II 1989-09-19
K893762 PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT Orthomet, Inc. JWH Class II 1989-09-15
K894149 MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL Howmedica Corp. JDI Class II 1989-09-14
K895079 ACE BEADED K-WIRES ACE OLIVE WIRES Buckman Co., Inc. HTY Class II 1989-09-13
K895173 SKELETAL FIXATION PIN Kronner Medical JDW Class II 1989-09-12
K895218 CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM Orthopedic Systems, Inc. HWC Class II 1989-09-12
K895217 CORTICAL SCREW Orthopedic Systems, Inc. HWC Class II 1989-09-12
K895219 CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM Orthopedic Systems, Inc. HWC Class II 1989-09-12
K895172 KRONNER SACRAL PIN GUIDE Kronner Medical LXH Class I 1989-09-12
K895107 ACE ORTHOPAEDIC WASHERS Buckman Co., Inc. HTN Class II 1989-09-11
K894124 OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS Osteonics Corp. HWC Class II 1989-09-11
K893872 P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT Johnson & Johnson Professionals, Inc. KWY Class II 1989-09-11
K894148 MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL Howmedica Corp. JDI Class II 1989-09-05
K885069 ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) Richards Medical Co., Inc. LZO Class II 1989-09-01
K890472 ATH CERAMIC UHMWPE TOTAL HIP SYSTEM Kinamed, Inc. LZO Class II 1989-09-01
K893455 THE HANDSCAN SYSTEM Digital Body Systems, Inc. KQX Class I 1989-08-30
K894830 CYPRESS CANNULATED BONE SCREW Cypress Medical Mfg., Inc. HWC Class II 1989-08-30
K894929 STAPLE FIXATION SYSTEM Concept, Inc. JDR Class II 1989-08-30
K894051 PREMIER-TOTAL HIP Intermedics Orthopedics LWJ Class II 1989-08-28
K891066 DANEK WRIST FIXATOR Danek Medical, Inc. KTT Class II 1989-08-28
K893512 DEPUY CANNULATED BONE SCREW Depuy, Inc. HWC Class II 1989-08-21
K894728 DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE Dyonics, Inc. HRX Class II 1989-08-18
K892638 TRACER DYNAMIC AXIAL FIXATION Tracer Medical JEC Class II 1989-08-11
K893785 ARC-2F ACETABULAR CUP Protek, Inc. LWJ Class II 1989-08-09
K894557 LIGHTSCOPE SET Optik HRW Class I 1989-08-07
K894558 MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET Optik HRX Class II 1989-08-07
K892925 VECSEI EXPANDING SCREW Howmedica Corp. HWC Class II 1989-08-07
K892800 MG II POROUS TOTAL KNEE SYSTEM Zimmer, Inc. JWH Class II 1989-08-03
K894249 UNIVERSAL CEMENTED CUP Orthopedic Systems, Inc. JDI Class II 1989-08-03
K893639 GAMMA LOCKING NAIL Howmedica Corp. KTT Class II 1989-08-03
K892376 INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) Concept, Inc. HRX Class II 1989-08-01
K893584 GRIPPER II ACETABULAR CUP Joint Medical Products Corp. LWJ Class II 1989-07-28
K893252 WHITESIDE ORTHOLOC M.A. TOTAL KNEE SYSTEM Dow Corning Wright JWH Class II 1989-07-28
K894303 MEDSCOPE 4MM ARTHROSCOPE Medscope Corp. HRX Class II 1989-07-25
K892651 SONGER WIRING SYSTEM Danek Medical, Inc. LRN Class II 1989-07-25
K893959 P.S.A. FEMORAL HIP PROSTHESIS Protek, Inc. KWY Class II 1989-07-25
K892366 POROUS GENESIS STEMMED TIBIAL COMPONENT Richards Medical Co., Inc. JWH Class II 1989-07-19
K892394 P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS Johnson & Johnson Professionals, Inc. JWH Class II 1989-07-19
K890132 POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP. Richards Medical Co., Inc. JWH Class II 1989-07-19
K892059 FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR Protek, Inc. LZY Class II 1989-07-19
K892062 PS3500 ARTHROSCOPIC SURGICAL SYSTEM Dyonics, Inc. HRX Class II 1989-06-23
K892214 REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW Ace Medical Co. HWC Class II 1989-06-22
K885192 APR COLLARED REVISION FEMORAL COMPONENT Intermedics Orthopedics JDI Class II 1989-06-22
K884998 SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. KWP Class II 1989-06-22
K885102 OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES) Osteonics Corp. LZO Class II 1989-06-22
K892937 REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS Dentsply Intl. JDZ Class I 1989-06-22
K890814 DANEK RING FIXATOR (DRF) Danek Medical, Inc. KTT Class II 1989-06-13
K891408 MODIFIED PROFILE HIP ACETABULAR PROSTHESIS Depuy, Inc. JDX Class II 1989-06-12
K891083 CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER Depuy, Inc. LZO Class II 1989-06-09
K891082 CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER Depuy, Inc. LZO Class II 1989-06-09
K891539 CTI II STRAIGHT STEM Orthopedic Systems, Inc. LWJ Class II 1989-06-08
K891454 EXETER II TOTAL HIP SYSTEM Howmedica Corp. JDI Class II 1989-06-07
K893415 TRANS-ORAL DEPTH GAUGE Ruggles Corp. LYQ Class I 1989-06-07
K891262 KDG ACETABULAR COMPONENT Osteonics Corp. LWJ Class II 1989-06-06
K890936 ALTA HOLLOW TIBIAL RODS Howmedica Corp. HSB Class II 1989-06-05
K884690 KIRSCHNER SPINAL FIXATOR KMS-1 Kirschner Medical Corp. KWP Class II 1989-06-02
K883794 RESUBMITTED CLW ACETABULAR CUP W/SULMESH Protek, Inc. LWJ Class II 1989-05-26
K892398 BIPOLAR HIP SYSTEM Orthomet, Inc. KXA Class II 1989-05-23
K890939 DUPONT DISTAL HUMERAL NAIL Howmedica Corp. HRS Class II 1989-05-22
K884739 SGARLATO LESSER TOE IMPLANT Sgarlato Laboratories, Inc. KWH Class II 1989-05-18
K891482 AML(R) COLLARLESS LATERALIZED FEMORAL HIP Depuy, Inc. KWL Class II 1989-05-16
K891903 COHN TARGETEER Orthopedic Systems, Inc. LXH Class I 1989-05-15
K890962 ORTHOPAEDIC STAPLES Ortho Spectrum, Inc. JDR Class II 1989-05-15
K884952 VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC Protek, Inc. LZO Class II 1989-05-10
K890742 INTRAFORM TOTAL HIP SYSTEM Orthomet, Inc. JDI Class II 1989-05-10
K884161 ACROMED ILIAC SCREW Buckman Co., Inc. KWP Class II 1989-05-03
K891472 IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR Implant Technology, Inc. LZV Class II 1989-05-02
K884943 INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID Intermedics Orthopedics KWS Class II 1989-04-27
K884163 ACROMED SPINAL ROD AND SPINAL HOOKS Buckman Co., Inc. KWP Class II 1989-04-26
K885146 CL UNIVERSAL HIP DEVICE Lima Intl. Corp. KWI Class II 1989-04-24
K883969 UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM Intermedics Orthopedics HRY Class II 1989-04-19
K885036 POROUS COATED GENESIS FEMORAL COMPONENT Richards Medical Co., Inc. JWH Class II 1989-04-19
K890285 PROSTHETIC CEMENT REMOVER Albert K. Chin LZV Class II 1989-04-19
K890197 OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT Osteonics Corp. KWZ Class II 1989-04-07
K884027 PERFECTA II/NON-COATED TOTAL HIP SYSTEM Orthomet, Inc. JDI Class II 1989-04-07
K890187 THE C-S DISTRACTION ROD ASSEMBLY Orthopedic Systems, Inc. KWP Class II 1989-04-06
K890185 C-S IMPACTOR Orthopedic Systems, Inc. LYP Class II 1989-04-06
K883784 TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE Warsaw Orthopedic, Inc. LYQ Class I 1989-04-06
K883783 TSRH SACRAL SPINAL SCREW Warsaw Orthopedic, Inc. KWP Class II 1989-04-06
K884796 P.F.C.(TM) MODULAR KNEE SYSTEM Johnson & Johnson Professionals, Inc. JWH Class II 1989-03-29
K885338 AML BOWED FEMORAL HIP Depuy, Inc. JDI Class II 1989-03-15
K890060 CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER Depuy, Inc. LZO Class II 1989-03-15
K884301 EDWARDS DISPOSABLE ARTHROSCOPY CANNULA Baxter Healthcare Corp HRX Class II 1989-03-13
K884314 LEONARD MEDICAL 1.7MM ARTHROSCOPE Leonard Medical, Inc. HRX Class II 1989-03-13
K890649 OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST. Osteonics Corp. JDI Class II 1989-03-13
K885183 ENDOSCOPIC LIGHT SOURCE Technology For Imaging, Inc. HRX Class II 1989-03-09
K884889 MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. Protek, Inc. KWL Class II 1989-02-27
K890641 ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES Acufex Microsurgical, Inc. HRS Class II 1989-02-27
K884688 MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD Synthes (Usa) KWP Class II 1989-02-24
K884837 KINEMAX TIBIAL WEDGE Howmedica Corp. HRY Class II 1989-02-17
K885250 ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS Howmedica Corp. HRS Class II 1989-02-13

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