meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
30
Latest Decision
1998-06-30

Clearances · page 133 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K981714 TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM Acromed Corp. MNH Class II 1998-06-30
K980813 RELIANCE LONG STEM FEMORAL COMPONENTS Howmedica, Inc. JDI Class II 1998-06-26
K981302 SMC 28MM CERAMIC FEMORAL HEADS Signal Medical Corp. LZO Class II 1998-06-25
K961320 CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM Buckman Co., Inc. HWC Class II 1998-06-25
K981269 UNIVERSAL DRIVE SYSTEM Linvatec Corp. HRX Class II 1998-06-24
K981261 HOWMEDICA SCN NAIL Howmedica Corp. HSB Class II 1998-06-22
K981670 DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW Depuy, Inc. HWC Class II 1998-06-22
K981340 INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM Innovasive Devices, Inc. MAI Class II 1998-06-22
K981309 OSTEO I-C HUMERAL NAIL SYSTEM Osteonics Corp. HSB Class II 1998-06-22
K974843 DURACON(R) SMALL STABILIZER TIBIAL INSERT Howmedica Corp. JWH Class II 1998-06-18
K974885 BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM Blackstone Medical, Inc. KWQ Class II 1998-06-17
K981193 INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER Innovasive Devices, Inc. MBI Class II 1998-06-16
K973812 ARTHREX PUDDU OSTEOTOMY SYSTEM Arthrex, Inc. HRS Class II 1998-06-10
K981283 ROGACHEFSKY DISTAL RADIUS PLATES Howmedica, Inc. HRS Class II 1998-06-10
K980121 AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS Aesculap, Inc. KWP Class II 1998-06-10
K981560 IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM Implex Corp. JWH Class II 1998-06-08
K980843 EXETER INTRAMEDULLARY BONE PLUG Howmedica, Inc. JDI Class II 1998-06-02
K981230 ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. HSB Class II 1998-06-01
K981201 OSTEOLOCK ACETABULAR CUP Howmedica Corp. LZO Class II 1998-05-29
K981113 PEDIATRIC PRC Acromed Corp. MNH Class II 1998-05-29
K980801 J-FX BIPOLAR HEAD Johnson & Johnson Professionals, Inc. KWY Class II 1998-05-29
K980766 OSTEONICS ANTEVERTED NECK HA HIP STEMS Osteonics Corp. MEH Class II 1998-05-27
K981008 SIMAL CERVICAL STABILIZATION SYSTEM Top Surgical Products GmbH KWQ Class II 1998-05-27
K981211 APR -T REVISION HIP STEM Sulzer Orthopedics, Inc. LPH Class II 1998-05-22
K980788 ALPHATEC WIRE EXTERNAL FIXATION SYSTEM Alphatec Mfg., Inc. JDW Class II 1998-05-22
K980713 FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM Howmedica Corp. JWH Class II 1998-05-22
K980690 CABLE SCREW WITH INTEGRAL CRIMP Pioneer Surgical Technology JDQ Class II 1998-05-22
K980781 IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS Implex Corp. JWH Class II 1998-05-22
K974245 DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI Depuy Ace Medical Co. LXT Class II 1998-05-22
K980981 OMEGA HA COATED TOTAL HIP SYSTEM Osteoimplant Technology, Inc. LPH Class II 1998-05-20
K980841 RCI FIXATION SCREWS Smith & Nephew, Inc. HWC Class II 1998-05-20
K980862 TITANIUM SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc MNH Class II 1998-05-20
K981156 DYONICS INTELIJET INFLOW/OUTFLOW CANNULA Smith & Nephew, Inc. HRX Class II 1998-05-20
K980794 DUAL LOCK HIP STEM Depuy, Inc. JDI Class II 1998-05-20
K981452 OSTEONICS LONG ARM CONTAINMENT RING Osteonics Corp. KWP Class II 1998-05-20
K981423 AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 Autogenesis, Inc. JEC Class II 1998-05-20
K980665 REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS Biomet, Inc. HRY Class II 1998-05-20
K980609 SEGMENTAL DEFECT REPLACEMENT SYSTEM Metagen, LLC HSB Class II 1998-05-18
K981372 SYNTHES 3.0 MM PC-FIX SYSTEM Synthes (Usa) HWC Class II 1998-05-11
K980928 SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM Synthes Spine KWP Class II 1998-05-11
K980595 DEPUY ORTHOTECH CATERA SUTURE ANCHOR DePuy Orthopaedics, Inc. MBI Class II 1998-05-11
K981259 OSTEO 4.0MM CANNULATED SCREW SYSTEM Osteonics Corp. HWC Class II 1998-05-11
K980502 OSTEONICS TOTAL ELBOW SYSTEM Osteonics Corp. JDC Class II 1998-05-05
K980428 BIOMET BIAXIAL TOTAL ELBOW Biomet, Inc. JDC Class II 1998-05-05
K980594 OSTEONICS FX-CABLELOK GRIP COMPONENTS Osteonics Corp. LYT Class II 1998-05-05
K980852 GII SPINAL FIXATION SYSTEM Karen E. Warden, M.E.B.E. MNH Class II 1998-05-01
K980681 INNOVASIVE DEVICES MENISCAL SCREW Innovasive Devices, Inc. HWC Class II 1998-04-29
K981274 ACROMED TIMX PLATE BASED LOW BACK SYSTEM Acromed Corp. MNH Class II 1998-04-29
K980364 HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS Howmedica Corp. HWC Class II 1998-04-29
K980774 OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS Osteonics Corp. LZO Class II 1998-04-29
K980491 INNOVASIVE LINX TIBIAL LIGAMENT FASTENER Innovasive Devices, Inc. MBI Class II 1998-04-29
K980545 THE NUFFIELD TOTAL KNEE SYSTEM Corin USA JWH Class II 1998-04-29
K980944 SYNTHES SCHUHLI IMPLANT SYSTEM Synthes (Usa) HTN Class II 1998-04-27
K980334 INNOVASIVE 10MM LINX HT LIGAMENT FASTENER Innovasive Devices, Inc. MBI Class II 1998-04-27
K973874 ACL CLIP-IN PLATE Innovasive Devices, Inc. MBI Class II 1998-04-24
K980276 STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM Stelkast Company JWH Class II 1998-04-24
K971407 JTECH COMMANDER AND ALGOMETER J-Tech Medical, Inc. HRW Class I 1998-04-20
K980358 SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM Synthes (Usa) KWP Class II 1998-04-16
K980473 PRESS-FIT STEM Encore Orthopedics, Inc. LZO Class II 1998-04-16
K973775 HARPOON SUTURE ANCHORS Biomet, Inc. MBI Class II 1998-04-16
K974341 MITEK BTB ABSORBABLE (PLA) CROSS PIN Mitek Products HTY Class II 1998-04-16
K980239 PARTNERSHIP CALCAR FEMORAL COMPONENTS Howmedica, Inc. LZO Class II 1998-04-16
K980363 ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) Orofacial Dynamics LBB Class II 1998-04-16
K980447 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM DePuy Orthopaedics, Inc. MNH Class II 1998-04-14
K980496 WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER Wrightmedicaltechnologyinc MNH Class II 1998-04-14
K980228 UNIVERSITY PLATE ANTERIOR SYSTEM Acromed Corp. KWQ Class II 1998-04-14
K980368 DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM Depuy, Inc. HRS Class II 1998-04-14
K980370 BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR Biomet, Inc. KTT Class II 1998-04-14
K980513 ARTICUL/EZE FEMORAL HEADS DePuy Orthopaedics, Inc. JDI Class II 1998-04-14
K980486 IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM Implex Corp. JDI Class II 1998-04-14
K972783 BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR Bionx Implants, Inc. MAI Class II 1998-04-14
K980081 S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD Johnson & Johnson Professionals, Inc. LZO Class II 1998-04-09
K973704 PROFUSION BONE VOID FILLER Biogeneration MQV Class II 1998-04-03
K980440 DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW Depuy, Inc. HWC Class II 1998-04-03
K980286 ULTIMA ACETABULAR ROOF REINFORCEMENT RING Johnson & Johnson Professionals, Inc. JDI Class II 1998-04-03
K980020 ACTIVELOCK MODULAR FEMORAL HIP SYSTEM Metagen, LLC LPH Class II 1998-04-03
K980102 BTI HUMERAL INTRAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. HSB Class II 1998-04-03
K972919 BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW Bionx Implants, Inc. HWC Class II 1998-03-27
K974876 BIONX DISTAL RADIUS SCREW Bionx Implants, Inc. MAI Class II 1998-03-20
K970599 TOWNLEY PEDICLE SCREW PLATING SYSTEM Danek Medical, Inc. MNI Class II 1998-03-20
K973687 SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM Spinal Concepts, Inc. MNH Class II 1998-03-18
K974740 DEPUY TRI-LOCK HIP STEM Depuy, Inc. LPH Class II 1998-03-18
K974908 SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES Synthes (Usa) HRS Class II 1998-03-18
K974186 ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING Orthofix Srl JDW Class II 1998-03-18
K974785 AUTO-DRIVE BONE SCREW Osteomed Corp. HWC Class II 1998-03-18
K974807 OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM Osteonics Corp. KWL Class II 1998-03-16
K973854 ORION ANTERIOR CERVICAL PLATE SYSTEM Sofamor Danek USA,Inc. KWQ Class II 1998-03-16
K980103 ACUMED SUTURE ANCHOR Acu Med, Inc. MBI Class II 1998-03-16
K974911 EXTERNAL FIXATOR Avanta Orthopaedics, Inc. JDW Class II 1998-03-16
K974720 HOWMEDICA(R) FULLY THREADED SCREWS Howmedica, Inc. HSB Class II 1998-03-13
K973405 YEUNG ENDOSCOPIC SPINE SYSTEM Richard Wolf Medical Instruments Corp. HRX Class II 1998-03-13
K974706 AESCULAP ABC CERVICAL PLATING SYSTEM Aesculap, Inc. KWQ Class II 1998-03-13
K974749 SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS Cross Medical Products, Inc. MNH Class II 1998-03-13
K974756 BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS Biodynamic Technologies, Inc. HWC Class II 1998-03-12
K974734 AURORA TITANIUM SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc MNH Class II 1998-03-10
K974781 DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL Depuy, Inc. HSB Class II 1998-03-10
K974603 PLAQUAGRAFE, AGRAFE P4V Atlas Technology HRS Class II 1998-03-10
K973836 SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM Cross Medical Products, Inc. MNH Class II 1998-03-05
K974291 MITEK BTB ABSORBABLE (PLA) CROSS PIN Mitek Products HTY Class II 1998-03-05
K974757 KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS Acromed Corp. KWQ Class II 1998-03-05

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