meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
36
Latest Decision
1998-10-28

Clearances · page 132 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K982662 DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW DePuy Orthopaedics, Inc. HWC Class II 1998-10-28
K983339 OSTEO DYNATROC PROXIMAL FEMORAL NAIL Osteonics Corp. HSB Class II 1998-10-27
K983014 SUMMIT ACETABULAR SYSTEM Johnson & Johnson Professionals, Inc. LPH Class II 1998-10-27
K983197 SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM) United States Surgical, A Division of Tyco Healthc KWP Class II 1998-10-26
K983265 DEPUY ACE COMPOSITE LOCKING NUT Depuy Ace Medical Co. HTN Class II 1998-10-26
K982133 OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT The Olympus Optical Co. HRX Class II 1998-10-22
K982987 SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM Synthes Spine MNI Class II 1998-10-21
K982936 OSTEONICS EXTENDED FEMORAL BEARING HEAD Osteonics Corp. LWJ Class II 1998-10-21
K983186 BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR Linvatec Corp. MAI Class II 1998-10-21
K982873 ZETA MULTIZONE SCN LOCKING NAIL Howmedica Corp. HSB Class II 1998-10-21
K982931 THREADED FIXATION PIN Sgarlato Laboratories, Inc. JDW Class II 1998-10-21
K982953 TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES Biomet, Inc. HSB Class II 1998-10-21
K983260 MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM Spinal Concepts, Inc. MNI Class II 1998-10-21
K983258 MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM Spinal Concepts, Inc. MNI Class II 1998-10-21
K982903 SULZER ORTHOPEDICS FLUTED STEMS Sulzer Orthopedics, Inc. JWH Class II 1998-10-21
K980485 ISOLA SPINAL SYSTEM Acromed Corp. MNI Class II 1998-10-21
K982990 TSRH SPINAL SYSTEM Sofamor Danek USA,Inc. MNI Class II 1998-10-21
K982545 BMP CABLE SYSTEM Biomet, Inc. JDQ Class II 1998-10-19
K982531 HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM Howmedica Corp. HRS Class II 1998-10-16
K982497 ARTHROTEK INTERFERENCE SCREW Biomet, Inc. HWC Class II 1998-10-16
K983056 INNOVASIVE TIBIAL FASTENER Innovasive Devices, Inc. MBI Class II 1998-10-13
K982982 MINI-FIXATOR FOR COLLES FRACTURES Biomet, Inc. HRS Class II 1998-10-13
K982484 EBI VUECATH ENDOSCOPIC SPINAL SYSTEM Electro-Biology, Inc. HRX Class II 1998-10-08
K982732 SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS) Synthes HRS Class II 1998-10-08
K982389 ODC B2 BIPOLAR CUP Ortho Development Corp. KWY Class II 1998-10-07
K982490 TENOR SPINAL SYSTEM Sofamor Danek USA,Inc. KWP Class II 1998-10-05
K982585 DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM DePuy Orthopaedics, Inc. JWH Class II 1998-10-05
K982918 DEPUY C-STEM SYSTEM DePuy Orthopaedics, Inc. JDI Class II 1998-10-05
K982886 OTI MODULAR SHOULDER SYSTEM Osteoimplant Technology, Inc. HSD Class II 1998-10-05
K983121 NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 Syntec Scientific Corp. HTY Class II 1998-10-05
K980484 AESCULAP SPINE SYSTEM EVOLUTION Aesculap, Inc. MNI Class II 1998-10-02
K982598 OTI FEMORAL LOCK TOTAL HIP SYSTEM Osteoimplant Technology, Inc. JDI Class II 1998-10-02
K982670 CONTEMPORARY ACETABULAR COMPONENT Howmedica Corp. JDI Class II 1998-10-02
K982375 STRYKER HIP ARTHOROSCOPY SET Stryker Endoscopy HRX Class II 1998-10-02
K982914 AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS Aesculap, Inc. MNI Class II 1998-10-02
K983152 OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS Osteonics Corp. MNH Class II 1998-09-25
K982266 HYDROCISION ARTHROJET SYSTEM Hydrocision, Inc. HRX Class II 1998-09-25
K982719 THE BONE TIE Surgicraft , Ltd. HTY Class II 1998-09-25
K980817 PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L Interpore Intl. MQV Class II 1998-09-25
K982869 ASCENT SYSTEM Biomet, Inc. JWH Class II 1998-09-22
K982553 OSTEO COMPRESSION HIP SCREW SYSTEM Osteonics Corp. HRS Class II 1998-09-22
K982571 KSEA FLIPPTACK KARL STORZ Endoscopy-America, Inc. MBI Class II 1998-09-22
K974685 OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS Osteonics Corp. JDI Class II 1998-09-22
K982483 DEPUY MOTECH PEAK FIXATION SYSTEM DePuy Orthopaedics, Inc. HRS Class II 1998-09-14
K982169 SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) Doctor'S Research Group, Inc. MBI Class II 1998-09-14
K982511 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS Depuy, Inc. KWP Class II 1998-09-14
K982602 RETROGRADE ROD SYSTEM Howmedica Corp. HSB Class II 1998-09-14
K982320 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM Depuy, Inc. KWP Class II 1998-09-14
K982390 CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) Wrightmedicaltechnologyinc KTW Class II 1998-09-14
K982601 OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL Osteonics Corp. HSB Class II 1998-09-14
K982494 BWM SPINE SYSTEM Howmedica Corp. KWP Class II 1998-09-08
K982288 RADIAL HEAD IMPLANT Avanta Orthopaedics, Inc. KWI Class II 1998-09-08
K980457 ENDO ABSORBABLE INTERFERENCE SCREW Endo Surgical Concepts, Inc. HWC Class II 1998-09-08
K982347 DEPUY ACE TIMAX PILON PLATE Depuy Ace Medical Co. HRS Class II 1998-08-31
K982068 HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM Howmedica Corp. JDW Class II 1998-08-31
K982900 PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW Depuy, Inc. MAI Class II 1998-08-31
K982248 HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A Howmedica, Inc. LPH Class II 1998-08-31
K982155 SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM Influence, Inc. MBI Class II 1998-08-31
K982908 MODIFICATION TO EBI SPINELINK SYSTEM Electro-Biology, Inc. KWP Class II 1998-08-28
K982367 REACH HIP COMPONENT Biomet, Inc. LPH Class II 1998-08-24
K982420 MITEK MICRO ANCHOR Mitek Products JDR Class II 1998-08-24
K981238 BIPOLAR FEMORAL HEAD Whiteside Biomechanics, Inc. KWY Class II 1998-08-21
K981451 ARGOMEDICAL BIPOLAR SYSTEM Stelkast Company KWL Class II 1998-08-21
K981636 INTEGRATED DRIVE/PUMP SYSTEM Linvatec Corp. HRX Class II 1998-08-20
K980854 RETROGRADE PEDIATRIC NAIL Encore Orthopedics, Inc. HTY Class II 1998-08-11
K982398 BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW Biomet, Inc. JDC Class II 1998-08-11
K980734 MYELOTEC VIDEO GUIDED CATHETER Myelotec, Inc. HRX Class II 1998-08-11
K981855 PRINCE MEDICAL CEMENT PLUG Prince Medical, Inc. JDI Class II 1998-08-10
K982686 MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM Sofamor Danek USA,Inc. MNI Class II 1998-08-07
K982011 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM DePuy Orthopaedics, Inc. KWP Class II 1998-08-06
K974847 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 Arthrex, Inc. MBI Class II 1998-08-06
K980761 SYNTHES SPINE PEDIATRIC ROD SYSTEM Synthes Spine MNH Class II 1998-08-04
K982302 IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS Implex Corp. JWH Class II 1998-07-31
K972913 MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM) Pacific Materials and Interfaces HRS Class II 1998-07-30
K981775 DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE Depuy Ace Medical Co. HRS Class II 1998-07-29
K982222 SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM Synthes (Usa) HWC Class II 1998-07-29
K980288 SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM Spine-Tech, Inc. KWP Class II 1998-07-29
K982156 PASCO MIC AND MIC/ID PANELS/ CEFDINIR Pasco Laboratories, Inc. JWJ Class II 1998-07-29
K982443 DOC VENTRAL CERVICAL STABILIZATION SYSTEM Depuy Motech Acromed KWQ Class II 1998-07-29
K981715 DISTAL RADIUS FRACTURE FIXATION PLATE Avanta Orthopaedics, Inc. HRS Class II 1998-07-29
K981692 MENISCAL REPAIR DEVICE Linvatec Corp. MBI Class II 1998-07-27
K981716 EXTERNAL FIXATION Avanta Orthopaedics, Inc. JDW Class II 1998-07-17
K981847 BIOLOX ALUMINA CERAMIC FEMORAL HEAD Smith & Nephew, Inc. LZO Class II 1998-07-17
K981967 WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE Arthrotek/Biomet, Inc. MBI Class II 1998-07-17
K981757 SYNTHES (USA) DHS HELIX SYSTEM Synthes (Usa) JDO Class II 1998-07-17
K981730 DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 Nk Biotechnical Corp. LBB Class II 1998-07-17
K982154 MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM Danek Medical, Inc. MNI Class II 1998-07-13
K981487 DEPUY GLOBAL SHOULDER GLENOID DePuy Orthopaedics, Inc. KWS Class II 1998-07-13
K981789 LORENZ PECTUS SUPPORT BAR STABILIZER Walter Lorenz Surgical, Inc. HRS Class II 1998-07-13
K981798 LACTOSORB POP RIVET Biomet, Inc. JDR Class II 1998-07-13
K981755 LM ANCHOR Li Medical Technologies, Inc. MBI Class II 1998-07-13
K981764 LM ANCHOR Li Medical Technologies, Inc. MBI Class II 1998-07-13
K981688 ANSPACH SUTURE ANCHOR The Anspach Effort, Inc. MBI Class II 1998-07-13
K972401 HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS Howmedica Corp. KRO Class II 1998-07-13
K981529 TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW Smith & Nephew, Inc. JDS Class II 1998-07-09
K982032 OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS Osteonics Corp. MEH Class II 1998-07-09
K981483 EBI DFS JOINT FIXATOR, MODEL 02800 Electro-Biology, Inc. KTT Class II 1998-07-08
K981251 KYPHON INFLATABLE BONE TAMP Kyphon, Inc. HRX Class II 1998-07-02
K981187 ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 Arthrex, Inc. HWC Class II 1998-07-01
K981194 FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT Nexa Orthopedics, Inc. KWH Class II 1998-06-30

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