meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
36
Latest Decision
1988-06-29

Clearances · page 161 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K880435 PROFORMA/PS TOTAL HIP SYSTEM Orthomet, Inc. JDI Class II 1988-06-29
K881769 HJD CALCAR REPLACEMENT PROSTHESIS Richards Medical Co., Inc. JDI Class II 1988-06-22
K882069 SPINAL DISTRACTORS, SPANNERS Karlin Technology, Inc. LXH Class I 1988-06-17
K882077 MICRODISCECTOMY CURRETTES Karlin Technology, Inc. LXH Class I 1988-06-17
K882068 COBB SPINAL ELEVATORS Karlin Technology, Inc. KWP Class II 1988-06-03
K881673 LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER Lima-Lto, Inc. JEC Class II 1988-06-03
K882070 LUMBAR IMPACTION SET AND BONE GRAFT IMPACTORS Karlin Technology, Inc. KWP Class II 1988-06-03
K881327 STUART CANNULATED CANCELLOUS BONE FIXATION SCREW Stuart Drug & Surgical Supply, Inc. HWC Class II 1988-05-25
K874377 ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY Harrington Arthritis Research Center LXT Class II 1988-05-20
K880269 LCS FEMORAL HIP PROSTHESIS Depuy, Inc. JDI Class II 1988-05-06
K881117 RESUBMITTING OF HJD TOTAL HIP SYSTEM Richards Medical Co., Inc. JDI Class II 1988-04-29
K881699 ACROMED WASHERS Buckman Co., Inc. HTN Class II 1988-04-27
K870088 S-ROM SUPERCUP ACETABULAR CUP Joint Medical Products Corp. LWJ Class II 1988-04-22
K881388 KIN-COM JR Chattanooga Group, Inc. LBB Class II 1988-04-21
K880203 HERMAN CANNULA SET Orthopedic Systems, Inc. HRX Class II 1988-04-14
K871867 ELITE MODULAR HIP SYSTEM Thackray USA JDI Class II 1988-04-08
K880390 INTRAFORM TOTAL HIP SYSTEM Orthomet, Inc. JDI Class II 1988-04-05
K880414 TENDON HARVESTER Concept, Inc. HRX Class II 1988-03-25
K880264 BONE SUTURE FIXATION DEVICE Orthopedic Systems, Inc. HXY Class I 1988-03-23
K881128 TITANIUM FEMORAL HIP Depuy, Inc. JDI Class II 1988-03-21
K880461 PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. JDI Class II 1988-03-15
K880381 TELOS DISTAL TARGETING DEVICE Austin Assoc. HXY Class I 1988-03-15
K880826 MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM Johnson & Johnson Professionals, Inc. KYK Class II 1988-03-14
K880737 SELF GUIDING (SG) INTERLOCKING NAIL Orthopaedic Designs, Inc. HSB Class II 1988-03-14
K874635 OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES Osteonics Corp. JWH Class II 1988-03-10
K880464 DYNATRON II Dynatronics Laser Corp. LBB Class II 1988-03-08
K874676 INTERFERENCE SCREW Concept, Inc. HWC Class II 1988-03-07
K880413 PATELLAR TENDON GRAFT GUIDE Concept, Inc. LXH Class I 1988-03-04
K880211 TSRH H/M HOOK HOLDER Warsaw Orthopedic, Inc. KWP Class II 1988-03-04
K875290 LUMBAR IMPACTION SET T. Korossurgical Instruments Corp. KWP Class II 1988-03-04
K880212 TSRH H/M HOOK HOLDER W/ROD MOVER Warsaw Orthopedic, Inc. KWP Class II 1988-03-04
K875166 PHARMASEAL STERILE UMBILICAL CORD CLAMP Baxter Healthcare Corp HWI Class I 1988-03-02
K880188 SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM Howmedica Corp. JDB Class II 1988-03-01
K880309 TYPE 316L STAINLESS STEEL WIRE Winn Hirsch & Assoc. JDQ Class II 1988-02-29
K874911 MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG Walter Lorenz Surgical, Inc. HRX Class II 1988-02-24
K874882 ACROMED CROSS ROD CONNECTOR Acromed Corp. KWP Class II 1988-02-18
K880004 TOWNLEY COX COMB ACETABULAR CUP Orthomet, Inc. JDI Class II 1988-02-18
K880331 HOOK PUNCH FORCEPS FOR ARTHROSCOPY Kibbutz Gilgal Medical C/O Toam U.S.A. Corp. HRX Class II 1988-02-18
K880215 TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD Warsaw Orthopedic, Inc. KWP Class II 1988-02-18
K880214 TSRH H/M TORQUE LIMITING WRENCH Warsaw Orthopedic, Inc. KWP Class II 1988-02-18
K871852 COXA ACETABULAR CUP Thackray USA JDI Class II 1988-02-18
K880282 LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER Lima-Lto, Inc. JEC Class II 1988-02-18
K874619 SPECTRON EF ACETABULAR COMPONENT Richards Medical Co., Inc. JDI Class II 1988-02-17
K880045 ACROMED AWL/PUNCH, DEPTH GAUGE Buckman Co., Inc. HWJ Class I 1988-02-17
K880156 VOLZ TOTAL WRIST PROSTHESIS Biomet, Inc. KWM Class II 1988-02-17
K875201 PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG Orthomet, Inc. JWH Class II 1988-02-17
K875223 DANNINGER ORTHOPAEDIC AWL Danninger Medical Technology, Inc. HWJ Class I 1988-02-17
K873331 ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG Directed Energy, Inc. HRX Class II 1988-02-17
K880046 HASTING FINGER FIXATOR INSTRUMENTS Buckman Co., Inc. HXY Class I 1988-02-16
K880205 EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES Baxter Healthcare Corp HRX Class II 1988-02-04
K874914 ORTHOMET ORTHOPEDIC STAPLES Orthomet, Inc. JDR Class II 1988-02-04
K874915 ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS Orthomet, Inc. KWL Class II 1988-02-03
K875249 SUTTER PHALANGEAL CAP Sutter Biomedical, Inc. KWD Class II 1988-02-03
K874599 MOORE HIP PROSTHESIS SOLID STEM Orthopedic Systems, Inc. JDI Class II 1988-01-29
K874616 MOORE HIP PROSTHESIS FENESTRATED STEM Orthopedic Systems, Inc. JDI Class II 1988-01-29
K875054 ACROMED ADS BONE NAIL DRIVER Buckman Co., Inc. HWR Class I 1988-01-28
K874093 SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP Protek, Inc. JDI Class II 1988-01-27
K873602 INTERMEDICS' NATURAL-KNEE(R) REVISION SYSTEM Intermedics Orthopedics JWH Class II 1988-01-27
K874868 OPTI-FIX COLLARED FEMORAL COMPONENTS Richards Medical Co., Inc. JDG Class II 1988-01-26
K875053 ACROMED CANCELLOUS BONE SCREW Buckman Co., Inc. HWC Class II 1988-01-20
K875156 STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM Richards Medical Co., Inc. JDQ Class II 1988-01-20
K873601 AGC UNICOMPARTMENTAL KNEE PROSTHESIS Biomet, Inc. HRY Class II 1988-01-20
K875012 ACE/FISCHER PERCUTANEOUS HALF PINS Buckman Co., Inc. JDW Class II 1988-01-14
K872768 OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT. Osteonics Corp. KWA Class III 1988-01-14
K875022 ACE/FISHER PERCUTANEOUS TRANSFIXING PINS Buckman Co., Inc. JDW Class II 1988-01-14
K875013 ACE PERCUTANEOUS 3MM HALF-PINS Buckman Co., Inc. JDW Class II 1988-01-14
K873619 ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS) Arthropedics, Inc. HRX Class II 1988-01-14
K875086 ORTHOMET BONE PLATES Orthomet, Inc. HRS Class II 1988-01-14
K874913 ORTHOMET PIN SYSTEM Orthomet, Inc. HTY Class II 1988-01-07
K874575 PROXIMAL FEMORAL REPLACEMENT PROSTHESIS Dow Corning Wright JDG Class II 1988-01-07
K875050 ORTHOMET BONE SCREWS Orthomet, Inc. HWC Class II 1988-01-07
K874919 ORTHOMET WIRE FOR SUTURE, CERCLAGE Orthomet, Inc. JDQ Class II 1988-01-07
K873660 ROPER-TUKE ELBOW Orthopedic Systems, Inc. JDB Class II 1988-01-06
K874643 KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS Kirschner Medical Corp. HSD Class II 1988-01-06
K873970 KIRSCHNER UNICONDYLAR KNEE SYSTEM Kirschner Medical Corp. HSX Class II 1987-12-31
K873626 FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM Orthopedic Systems, Inc. JDI Class II 1987-12-31
K874100 AML CALCAR FEMORAL PROSTHESIS Depuy, Inc. JDG Class II 1987-12-31
K874954 MANUAL RONGEUR Solway, Inc. HTX Class I 1987-12-30
K875021 ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM Buckman Co., Inc. JDW Class II 1987-12-30
K873627 CTI STRAIGHT STEM Orthopedic Systems, Inc. JDG Class II 1987-12-30
K874880 COLORED CASTING TAPE CARAGLAS(TM GREEN Synthetic Mfg., Inc. LGF Class I 1987-12-30
K874547 KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED Kirschner Medical Corp. JWH Class II 1987-12-18
K874740 WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO Dow Corning Wright JDG Class II 1987-12-18
K874670 ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW Buckman Co., Inc. HWC Class II 1987-12-17
K874672 ACE CORTICAL LAG SCREW Buckman Co., Inc. HWC Class II 1987-12-11
K874669 ACE BONE SCREW NUT Buckman Co., Inc. HTN Class II 1987-12-11
K874617 THOMPSON HIP PROSTHESIS Orthopedic Systems, Inc. JDG Class II 1987-12-10
K873723 PLASTER VACUUM, 230V MODEL NO. 4183-161 Martin Medical LGH Class I 1987-12-10
K873721 PLASTER VACUUM, 115V MODEL NO. 4183-160 Martin Medical LGH Class I 1987-12-07
K872715 UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY Roseburg SA JDN Class II 1987-12-07
K873977 NEW C-D SYSTEM FOR SPINAL SURGERY Sofamor Co. JDN Class II 1987-12-07
K873632 HI-NEK TOTAL HIP Orthopedic Systems, Inc. JDI Class II 1987-12-07
K874130 TITANIUM BONE SCREWS Orthopedic Systems, Inc. HWC Class II 1987-12-07
K873857 WHITESIDE ORTHOLOC REVISION HIP STEM PROSTHESIS Dow Corning Wright JDI Class II 1987-12-01
K874515 CONCEPT SUTURE NEEDLE Concept, Inc. HRX Class II 1987-11-27
K874593 ACE SELFTAPPING CANCELLOUS BONE SCREW Ace Medical Co. HWC Class II 1987-11-24
K874358 COMBINATION WRENCHES Med-Tool, Inc. HXC Class I 1987-11-23
K874359 ADJUSTABLE WRENCHES Med-Tool, Inc. HXC Class I 1987-11-23
K873679 SELECT SHOULDER SYSTEM Intermedics Orthopedics HSD Class II 1987-11-17
K874229 ANATOMIC TOTAL HIP Zimmer, Inc. JDI Class II 1987-11-03

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