meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
37
Latest Decision
1989-02-13

Clearances · page 160 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K890160 GOUGES FOR FEMORAL HEADS Dhason Brothers, Inc. LXH Class I 1989-02-13
K890161 THOMPSON TYPE RASP W/TOMMY BAR Dhason Brothers, Inc. LXH Class I 1989-02-13
K890157 FORCEPS Dhason Brothers, Inc. LXH Class I 1989-02-13
K890163 AUSTIN MOORE HALLOW CHISEL Dhason Brothers, Inc. LXH Class I 1989-02-13
K890158 RETRACTORS Dhason Brothers, Inc. LXH Class I 1989-02-13
K890164 HUDSON BRACE W/BURRS Dhason Brothers, Inc. LXH Class I 1989-02-13
K890156 IMPACTOR FOR FEMORAL HEAD Dhason Brothers, Inc. LXH Class I 1989-02-13
K890166 RONGUER-ORTHOPEDIC Dhason Brothers, Inc. LXH Class I 1989-02-13
K890162 EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD Dhason Brothers, Inc. LXH Class I 1989-02-13
K890168 RETRACTOR, SELF-RETAINING Dhason Brothers, Inc. LXH Class I 1989-02-13
K884798 AME PINSITE SHIELD(TM) American Medical Electronics, Inc. JEC Class II 1989-02-10
K885311 MENISCUS MENDER II LOOP Instrument Makar, Inc. HWQ Class I 1989-02-09
K890054 M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. Protek, Inc. JDI Class II 1989-02-08
K884789 NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI Protek, Inc. KWL Class II 1989-02-08
K882322 CONTINUUM KNEE SYSTEM (CKS) Buckman Co., Inc. JWH Class II 1989-02-08
K885305 ACETABULAR CUP PUSHER/IMPACTOR Cobot Medical Corp. HXO Class I 1989-02-08
K884723 (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM Greenleaf Medical Systems, Inc. KQX Class I 1989-02-08
K883661 MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS) Depuy, Inc. LWJ Class II 1989-02-08
K883665 COONRAD III TOTAL ELBOW Zimmer, Inc. JDC Class II 1989-02-03
K890167 HOLDER, NEEDLE Dhason Brothers, Inc. HXK Class I 1989-02-03
K884338 LACEY POSTERIOR STABILIZED KNEE SYSTEM Dow Corning Wright JWH Class II 1989-02-01
K884611 THE ORTHORANGER II ELECTRONIC GONIOMETER Medical Instruments Technology, Inc. KQX Class I 1989-01-31
K875130 BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS Orthopedic Systems, Inc. HRX Class II 1989-01-30
K883882 HUMERAL LOCKING NAIL SYSTEM Howmedica Corp. JDS Class II 1989-01-30
K884585 LEA PLAZA SPINAL FRAME SYSTEM Orthomet, Inc. KWP Class II 1989-01-27
K890212 MICROSURGICAL SCISSORS Kinetic Medical Products HRR Class I 1989-01-27
K890225 SURGICAL SCISSORS Kinetic Medical Products HRR Class I 1989-01-27
K890261 TRIGEMINAL SCISSORS Kinetic Medical Products HRR Class I 1989-01-27
K890227 SURGICAL PROBE Kinetic Medical Products HXB Class I 1989-01-27
K884500 ALTA NON-REAMED TIBIAL ROD Howmedica Corp. HSB Class II 1989-01-18
K884410 OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM Osteonics Corp. JWH Class II 1989-01-18
K884398 OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS Osteonics Corp. JWH Class II 1989-01-17
K885100 MCCONNELL REAMER GUIDE Mcconnell Orthopedic HTO Class I 1989-01-13
K885049 RS-CUP ACETABULAR PROSTHESIS Allo Pro Corp. KWA Class III 1989-01-13
K884242 MODIFIED CHICK AMBULATORY HALO Chick Medical Products JEC Class II 1988-12-29
K884888 MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS Protek, Inc. JDI Class II 1988-12-29
K884263 ROGOZINSKI SPINAL SYSTEM Richards Medical Co., Inc. KWP Class II 1988-12-29
K883618 PERFECTA II TOTAL HIP SYSTEM Orthomet, Inc. JDI Class II 1988-12-28
K884003 GONIOMETER AND BIOMEDICAL RECORDER SYSTEM Penny & Giles Blackwood , Ltd. KQX Class I 1988-12-19
K884432 MODIFIED LSF TOTAL HIP SYSTEM Implant Technology, Inc. JDI Class II 1988-12-09
K882469 CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES Orthoconcept, Inc. HRX Class II 1988-12-01
K883122 AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT Depuy, Inc. JWH Class II 1988-12-01
K884610 INTERLOCKING INTRAMEDULLARY NAILS Depuy, Inc. HSB Class II 1988-12-01
K883941 PROFORMA HIP SYSTEM Orthomet, Inc. JDI Class II 1988-11-30
K884658 ZIMMER BEADED THREADED ACETABULAR CUP Zimmer, Inc. KWY Class II 1988-11-30
K873826 ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION Acromed Corp. KWQ Class II 1988-11-30
K884302 EDWARDS ARTHROSCOPIC LEG HOLDER Baxter Healthcare Corp HRX Class II 1988-11-30
K884406 TRACER HIP PINNING SYSTEM De Medica Mfg., Inc. JDS Class II 1988-11-28
K884407 TRACER SKELETAL TRACTION PINS De Medica Mfg., Inc. HSB Class II 1988-11-28
K883694 TENSIOMETER W. L. Gore & Associates, Inc. LXH Class I 1988-11-22
K883212 LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT Implant Technology, Inc. KXA Class II 1988-11-22
K884457 MODULAR COLLARED HJD TOTAL HIP SYSTEM Richards Medical Co., Inc. JDI Class II 1988-11-17
K883724 GEMINI FEMORAL HIP PROSTHESIS Depuy, Inc. JDI Class II 1988-11-16
K883816 SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS Osteonics Corp. KWS Class II 1988-11-10
K883215 KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S Kirschner Medical Corp. JWH Class II 1988-11-09
K883300 IRRIGATION SET Edwards Orthopaedics Div., Baxter Healthcare Corp. HRX Class II 1988-11-01
K884165 MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS Spark Instruments & Academics, Inc. LBB Class II 1988-10-26
K882234 JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS Johnson & Johnson Professionals, Inc. JWH Class II 1988-10-20
K882671 SAMUELSON SCREWLOC CUP Protek, Inc. KWA Class III 1988-10-20
K882869 TOWNLEY COX COMB ACETABULAR COMPONENT Biopro, Inc. JDI Class II 1988-10-14
K883361 ARTHRO-TRAC(TM) Rudolph Beaver, Inc. HRX Class II 1988-10-13
K883921 OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING Osteonics Corp. LWJ Class II 1988-10-13
K882934 CASF CANCELLOUS BONE SCREW, BT650 Terray Manufacturing, Inc. HWC Class II 1988-10-13
K874923 PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE Howmedica Corp. JWH Class II 1988-10-12
K883910 ACUFEX INTERFERENCE SCREW AND SCREWDRIVER Acufex Microsurgical, Inc. HWC Class II 1988-10-12
K883183 TRACER BONE MILL De Medica Mfg., Inc. LYS Class I 1988-10-12
K884132 TECNOL BUCKS TRACTION W/HEEL PROTECTOR Technol, Inc. KQZ Class I 1988-10-11
K883460 FOCUS TOTAL HIP SYSTEM Depuy, Inc. JDI Class II 1988-10-11
K881983 HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT Howmedica Corp. LWJ Class II 1988-10-06
K882967 BONE FIXATION WIRE Baxter Healthcare Corp JDQ Class II 1988-09-30
K882877 JMS CERVICAL TRACTION DEVICE/HALO DEVICE Jerome Medical JEC Class II 1988-09-30
K883576 HORIZON ORTHOPEDIC PIN PROTECTOR Horizon Medical, Inc. LYT Class II 1988-09-30
K882871 CASF DRILL GUIDE DG 170 Terray Manufacturing, Inc. LYQ Class I 1988-09-23
K883179 HIP FRACTURE STEM SYSTEM Howmedica Corp. KWL Class II 1988-09-22
K882525 SPINAL MICROKNIFE Karlin Technology, Inc. HTS Class I 1988-09-22
K883715 AXIAL COMPRESSION SCREW Straub Clinic and Hospital KTT Class II 1988-09-22
K882922 TECHMEDICA MP SYSTEM Techmedica, Inc. KTT Class II 1988-09-22
K881779 WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM Dow Corning Wright HSX Class II 1988-08-31
K883294 SYNTHETIC CAST TAPE Carapace, Inc. LGF Class I 1988-08-30
K881715 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES KARL STORZ Endoscopy-America, Inc. HRX Class II 1988-08-30
K881750 NORMAL HUMERAL PROSTHESIS Osteonics Corp. KWS Class II 1988-08-30
K882146 BIOPRO PC FEMORAL HIP COMPONENT Biopro, Inc. JDI Class II 1988-08-29
K881836 INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP Intermedics Orthopedics KWS Class II 1988-08-29
K882454 LUHR MICRO SYSTEM Howmedica Corp. HRS Class II 1988-08-19
K882675 ATH METAL:UHMWPE TOTAL HIP SYSTEM Kinamed, Inc. KWA Class III 1988-08-19
K882812 OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM Osteonics Corp. JDI Class II 1988-08-08
K882890 WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM Thackray USA JDQ Class II 1988-08-08
K880155 MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE Zimmer, Inc. HSX Class II 1988-08-03
K882831 ACE CANCELLOUS BONE SCREW Buckman Co., Inc. HWC Class II 1988-08-01
K881896 KIRSCHNER SUPER-FIXATION SYSTEM Kirschner Medical Corp. JEC Class II 1988-07-28
K882640 TECNOL SECURE-ALL PELVIC TRACTION BELT Tecnol New Jersey Wound Care, Inc. KQZ Class I 1988-07-27
K881703 3M CARPAL TUNNEL 3M Company HRX Class II 1988-07-25
K881982 PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP Howmedica Corp. JWH Class II 1988-07-19
K881792 CANNULA MODEL AR-6551 Arthrex Arthroscopy Instruments, Inc. HRX Class II 1988-07-07
K881511 FIXATOR PIN (EXTERNAL) Orthopedic Systems, Inc. JDW Class II 1988-06-30
K882443 ZINDRICK IM ROD INSTRUMENTS Buckman Co., Inc. HSB Class II 1988-06-30
K880295 CANNULA MODEL AR-6001 Arthrex Arthroscopy Instruments, Inc. HRX Class II 1988-06-29
K881288 CORIN MODULAR MOORE STEM Orthopedic Systems, Inc. LWJ Class II 1988-06-29
K882241 KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM Kirschner Medical Corp. HRY Class II 1988-06-29
K881289 CORIN BIPOLAR PROSTHESIS Orthopedic Systems, Inc. KWY Class II 1988-06-29

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