meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
46
Latest Decision
1985-04-19

Clearances · page 166 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K850442 MEC BROAD BONE PLATE Pfizer, Inc. HRS Class II 1985-04-19
K850401 LETOURNEL ACETABULAR PLATE Pfizer, Inc. HRS Class II 1985-04-19
K850770 INTERMEDICS BONE SCREW Intermedics Orthopedics HWC Class II 1985-04-19
K850444 MEC BUTRESS PLATE Pfizer, Inc. HRS Class II 1985-04-19
K844787 BIOMETRIC TOTAL HIP SYSTEM Biomedics JDI Class II 1985-04-19
K850441 MEC INTRAMEDULLARY ROD Pfizer, Inc. HSB Class II 1985-04-19
K843942 HENNING MENISCAL SUTURE KIT Stryker Corp. LXH Class I 1985-04-15
K850082 HAND HELD GONIOMETER Chattanooga Group, Inc. KQW Class I 1985-04-04
K844943 WEILL CEMENTLESS THREADED ACETABULAR CUP Advanced Biosearch Assn. KWA Class III 1985-03-18
K844817 MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM Osteonics Corp. JDI Class II 1985-03-12
K844488 MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS Mecron Medical Products, Inc. KWL Class II 1985-03-12
K844941 CFE ACETABULAR CUP Biomet, Inc. JDI Class II 1985-03-05
K844906 THREADED TITANIUM METAL BACKED ACETABULAR CUP Depuy, Inc. LZO Class II 1985-03-05
K845005 BROOKER ACETABULAR CUP Biomet, Inc. JDI Class II 1985-02-21
K844706 TRICON REVISION TOTAL KNEE SYSTEM Richards Medical Co., Inc. HSX Class II 1985-02-19
K844487 MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR Mecron Medical Products, Inc. KWL Class II 1985-02-19
K844482 MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT Advanced Biosearch Assn. JDL Class III 1985-02-19
K844486 MECRON MRC-HEADLESS FEMORAL COMPONENT Mecron Medical Products, Inc. KWL Class II 1985-02-19
K842493 AGEE EXTERNAL FIXATOR The Hand Biomechanics Research Laboratory JEC Class II 1985-02-13
K843445 SACRAL BAR Stuart KWP Class II 1985-02-13
K844028 LORD SCREW RING ACETABULAR COMPONENT Howmedica Corp. JDI Class II 1985-02-12
K844355 SYNATOMIC STANDARD TIBIAL PLATEAU Depuy, Inc. HSX Class II 1985-02-07
K850142 ACE INTRAMEDULLARY ROD FOR SMALL BONES Buckman Co., Inc. HSB Class II 1985-02-07
K841241 ANTERIOR CRUCIATE LIGAMENT GRASPER Surgical Products Corp. HRX Class II 1985-02-06
K842466 TITANIUM MITTELMEIER TYPE ACETABULAR American Ortomed Corp. KWA Class III 1985-01-30
K842518 UNILOC-CEMENTLESS & SELF TAP ACETABULAR American Ortomed Corp. KWA Class III 1985-01-30
K843370 IMSI/METRIPOND GRIPPER PLATE Intl. Management Services, Inc. HRS Class II 1985-01-23
K844415 POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS Depuy, Inc. MBF Class II 1985-01-23
K843624 COFIELD SHOULDER SYSTEM Richards Medical Co., Inc. KWS Class II 1985-01-10
K843907 POROUS COATED TITANIUM KNEE PROSTHES- Johnson & Johnson Professionals, Inc. JWH Class II 1985-01-10
K843687 ROD FOR RACHIS SURGERY Sofamor Co. KWP Class II 1985-01-10
K842559 WHITESIDE ORTHOLOC TOTAL HIP FEMORAL Dow Corning Corp. Healthcare Industries Materials KWL Class II 1984-12-20
K843219 ZIMMER BONE CEMENT CENTRIFUGATION SYS Zimmer, Inc. JDZ Class I 1984-11-29
K840566 BONE STAPLING FIXATION SYS 3M Company JDR Class II 1984-11-23
K842465 UNILOC American Ortomed Corp. KWL Class II 1984-11-19
K844239 NEC-KRADLE BY VENCOR Vencor HST Class I 1984-11-19
K843190 HAP ACETABULAR CUP Depuy, Inc. JDI Class II 1984-11-16
K843909 TITANIUM HIP 1019 Depuy, Inc. JDI Class II 1984-11-15
K843780 VENT-A-CAST Orthopedic Technology, Inc. LGF Class I 1984-11-14
K842893 DORR HIP PROSTHESIS, ACETABULAR COMPON Carbomedics, Inc. JDL Class III 1984-11-08
K842977 ORTHOPAEDIC CABLE SYSTEM Richards Medical Co., Inc. JDQ Class II 1984-10-26
K843604 RICHARD ARTHROSCOPE Richards Medical Co., Inc. HRX Class II 1984-10-22
K843449 AUTODYNAMIC COMPRESSION HIP SCREW-PLATE Mecron Medical Products, Inc. KTT Class II 1984-10-22
K843592 VICO MICRO SURGICAL INSTRUMENTS Visitec Co. HWQ Class I 1984-10-05
K842360 DORR HIP PROSTHESIS FEMORAL COMPONENT Carbomedics, Inc. JDI Class II 1984-10-02
K843553 BONE PLATES Mecron Medical Products, Inc. KTW Class II 1984-10-01
K843554 BONE SCREWS Mecron Medical Products, Inc. KTW Class II 1984-10-01
K843242 TRICON M TIBIAL COMPONENT Richards Medical Co., Inc. JWH Class II 1984-09-26
K843241 TRICON-P TIBIAL COMPONENT Richards Medical Co., Inc. JWH Class II 1984-09-26
K842681 T.O.D. PLATE SYSTEM Kirschner Medical Corp. KTT Class II 1984-09-25
K842695 T.O.D. PLATE SYS STERILE Kirschner Medical Corp. KTT Class II 1984-09-25
K842768 ACE/FISHER EXTERNAL FIXATOR Buckman Co., Inc. KTT Class II 1984-09-21
K841621 BACK RADIUS CUTTER Plastafil, Inc. HTX Class I 1984-09-20
K841620 FRONT RADIUS CUTTER Plastafil, Inc. HTX Class I 1984-09-20
K831792 SELF-ALIGNING ACETABULAR COMPONENT Endomedics, Inc. JDL Class III 1984-09-20
K842344 HASTINGS BIPOLAR ENDOPROSTHESIS Johnson & Johnson Professionals, Inc. KWY Class II 1984-09-12
K843368 KAPP SPINAL BUTTON Kapp Surgical Instrument, Inc. HTN Class II 1984-09-12
K842343 SABA-COOMBS MINI EXTERNAL FIXATOR Zimmer, Inc. JEC Class II 1984-09-11
K843208 ACUFEX ARTHROSCOPE Acufex Microsurgical, Inc. HRX Class II 1984-09-11
K841626 PUNCH Plastafil, Inc. HXG Class I 1984-08-27
K841627 MALLET Plastafil, Inc. HWA Class I 1984-08-27
K841629 DRILL BIT Plastafil, Inc. HTW Class I 1984-08-27
K841624 PROBE Plastafil, Inc. HRX Class II 1984-08-27
K842906 BIAS TOTAL HIP Zimmer, Inc. JDI Class II 1984-08-24
K842953 ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL All-Hands Medical Supply, Inc. HRR Class I 1984-08-21
K841607 AMERICAN EDWARDS LABS FLEXISCOPE American Edwards Laboratories HRX Class II 1984-08-18
K842323 AMER. EDWARDS LAB FLEXISCOPE OBTURATOR American Edwards Laboratories HRX Class II 1984-08-17
K842367 HOWMEDICA KINEMATIC II TIBIAL WEDGE Howmedica Corp. HRY Class II 1984-08-17
K842820 ARTHROSCOPY KNIVES Medtech Industries, Inc. HTS Class I 1984-08-14
K842293 PARTIALLY THREADED BONE FIX. PIN Warsaw Orthopedic, Inc. JDW Class II 1984-08-02
K841628 WIRE Plastafil, Inc. HXN Class I 1984-07-23
K842234 NEW JERSEY FEMORAL STEM Endomedics, Inc. KWL Class II 1984-07-20
K842202 NEW JERSEY ACETABULAR COMPONENT & Endomedics, Inc. JDI Class II 1984-07-20
K842233 NEW JERSEY FEMORAL RESURFACING COMPONENT Endomedics, Inc. KXA Class II 1984-07-20
K841622 SOFT-TISSUE INSTRUMENT Plastafil, Inc. HWQ Class I 1984-07-11
K841623 SLOTTED SOFT-TISSUE INSTRUMENT Plastafil, Inc. HWQ Class I 1984-07-11
K841687 SKYNDEX ELECTRONIC BODY FAT CALCULA Caldwell, Justiss & Co., Inc. KTZ Class I 1984-06-28
K841437 PENNSYLVANIA HOSPITAL HIP SYS Biomet, Inc. KWL Class II 1984-06-25
K841969 6.5MM HEX HANDLE Stainless Mfg., Inc. LXH Class I 1984-06-19
K841981 4MM & 5MM FILE Stainless Mfg., Inc. HTP Class I 1984-06-19
K841970 CAMELBACK HANDLE-K841969-LABELING Stainless Mfg., Inc. LXH Class I 1984-06-19
K834035 UNIVERSAL SELF-ALIGNING ACETABULAR COM Orthopedic Equipment Co., Inc. JDI Class II 1984-06-19
K841971 2.5MM & 4MM PROBE K841969-LABELING Stainless Mfg., Inc. HXB Class I 1984-06-19
K840242 POLY PLUG CEMENT RESTRICTOR Latham Manufacturer JDS Class II 1984-05-30
K841470 REESE OSTEOTOMY GUIDE SYS Osteotomy Guide Co. HTH Class I 1984-05-23
K841388 ACUFEX SHOULDER HOLDER Acufex Microsurgical, Inc. HST Class I 1984-05-16
K841189 OEC/REZAIAN SPINAL FIXATOR Orthopedic Equipment Co., Inc. KWQ Class II 1984-05-16
K841368 HYPERBARIC OXYGEN GURNEY- Orthopedic Systems, Inc. HST Class I 1984-05-16
K841334 RICHARDS FIXATOR SYSTEM Richards Medical Co., Inc. JEC Class II 1984-05-16
K841087 FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 Machida America, Inc. HRX Class II 1984-05-16
K840735 FEMORAL CEMENT REMOVAL INSTRUMENT Amtech Scientific, Inc. HWX Class I 1984-05-14
K840954 DYNAMIC CONDYLAR SCREW OR D.C.S. Synthes (Usa) HRS Class II 1984-05-11
K840492 SUN-LITE BLUE SLIT Suncoast Medical Manufacturers, Inc. HTP Class I 1984-05-09
K840856 MODULAR CONSTRUCT FRAME EXTERNAL FIXA Precision Medical Devices, Inc. JEC Class II 1984-04-25
K840558 SHUTT PRECISION PROBES Concept, Inc. HXB Class I 1984-04-25
K834515 FIXATION STAPLE KIT - DLIDE HAMMER Stryker Corp. HXJ Class I 1984-04-23
K840643 HARRIS-GALANTE POROUS TOTAL HIP SYS Zimmer, Inc. JDI Class II 1984-04-17
K841391 WEBER-STUHMER HIP PROSTHESIS STEM Allo Pro Corp. JDI Class II 1984-04-13
K834432 ANTHRO-MODULAR TOTAL KNEE Zimmer, Inc. JWH Class II 1984-04-11
K833681 POROCOAT HPS II HIP PROSTHESIS Depuy, Inc. LPH Class II 1984-03-27

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