meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
32
Latest Decision
1999-10-05

Clearances · page 129 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K992782 NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES Nuvasive, Inc. HRX Class II 1999-10-05
K990324 NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM Nuvasive, Inc. HRX Class II 1999-10-05
K993111 ASCENT KNEE SYSTEM Biomet Manufacturing, Inc. JWH Class II 1999-10-05
K992276 MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM Sulzer Spine-Tech MNI Class II 1999-10-01
K992876 VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM Mitek Products HRX Class II 1999-09-24
K992367 EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS Electro-Biology, Inc. HWC Class II 1999-09-23
K992474 ARTHROSCOPE / MEDIFIX INC. Medifix, Inc. HRX Class II 1999-09-23
K992153 PE-PLUS ACETABULAR CUP Plus Orthopedics JDI Class II 1999-09-23
K992938 ROTORBLADE SUTURE ANCHOR Li Medical Technologies, Inc. MAI Class II 1999-09-23
K992348 SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) Synthes (Usa) JDS Class II 1999-09-23
K992168 MOSS MIAMI 6.35MM POLYAXIAL SCREW Depuyacromed KWQ Class II 1999-09-23
K992611 MITEK ROTATOR CUFF QUICKANCHOR PLUS Mitek Products HWC Class II 1999-09-22
K992350 PYLON INTRAMEDULLAARY NAIL SYSTEM Alphatec Mfg., Inc. HSB Class II 1999-09-22
K992144 BIOPRO RIMMED ACETABULAR COMPOMENT Biologically Oriented Prostheses LZO Class II 1999-09-22
K992487 MITEK MINI QUICKANCHOR PLUS Mitek Products HWC Class II 1999-09-21
K992947 CANNULATED SMARTSCREW MODELS 224540C, 224570C Bionx Implants, Ltd. HWC Class II 1999-09-21
K992928 CD HORIZON SPINAL SYSTEM Sofamor Danek USA,Inc. MNI Class II 1999-09-21
K992106 MODUS SYSTEM SELF-DRILLING SCREWS Medartis AG HWC Class II 1999-09-17
K992903 COLOR BUFFED CEMENTED FEMORAL Biomet, Inc. JDI Class II 1999-09-17
K990194 BIOBUTTON Linvatec Corp. HWC Class II 1999-09-17
K992110 PREMIER ANTERIOR CERVICAL PLATE SYSTEM Sofamor Danek USA KWQ Class II 1999-09-14
K991036 DANEK PLATE AND SCREW SYSTEM Sofamor Danek USA,Inc. MNH Class II 1999-09-14
K992119 BIO-MODULAR SHOULDER SYSTEM Biomet, Inc. KWS Class II 1999-09-13
K991990 TRI-POLAR SYSTEM Biomet, Inc. KWY Class II 1999-09-10
K990148 STACKABLE CAGE SYSTEM Depuy Motech Acromed MQP Class II 1999-09-03
K992063 OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY Howmedica Osteonics Corp. HSB Class II 1999-09-03
K991915 MODULAR RADIAL HEAD Wrightmedicaltechnologyinc KWI Class II 1999-09-03
K992570 UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE Howmedica Osteonics Corp. KWL Class II 1999-09-01
K992301 REUNITE SCREWS Biomet Manufacturing, Inc. HWC Class II 1999-09-01
K990261 PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) Plus Orthopedics LZO Class II 1999-08-27
K992567 ANATOMICAL BANKART TACK, MODEL 523520A Bionx Implants, Ltd. MAI Class II 1999-08-27
K991055 OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM Howmedica Osteonics Corp. MNH Class II 1999-08-27
K991089 SYNTHES CERVIFIX SYSTEM Synthes Spine KWP Class II 1999-08-27
K991198 DYNA-LOK PLUS SPINAL SYSTEM Sofamor Danek USA,Inc. KWP Class II 1999-08-27
K991854 OSTEOPLAST, MODEL POP200 Interpore Cross Intl. MQV Class II 1999-08-26
K980244 AEQUALIS SHOULDER PROSTHESIS Tornier KWS Class II 1999-08-23
K992490 B2C HIP SYSTEM Lepine Groupe Spa. JDI Class II 1999-08-19
K991941 EBI XFIX DFS RAIL SYSTEM Electro-Biology, Inc. KTT Class II 1999-08-19
K991585 BIPOLAR SHOULDER PROSTHESIS Biomet, Inc. KWT Class II 1999-08-18
K992515 EBI XFIX DFS OPTIROM ELBOW FIXATOR Ebi, L.P. KTT Class II 1999-08-17
K991873 KMI WRIST FUSION SYSTEM Kinetikos Medical, Inc. HRS Class II 1999-08-17
K991753 MAXIM REMOVABLE MOLDED POLY TIBIA Biomet, Inc. JWH Class II 1999-08-17
K992025 PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING Howmedica Osteonics Corp. MEH Class II 1999-08-13
K991721 EBI OMEGA 21 SYSTEM Ebi Electro Biology MNI Class II 1999-08-13
K983577 ARTHREX MENISCAL DART SYSTEM Arthrex, Inc. MAI Class II 1999-08-13
K991794 ENDOSCOPIC SPINAL ACCESS SYSTEM Endius, Inc. HRX Class II 1999-08-13
K984304 RIWO DRIVE GENERATOR Richard Wolf Medical Instruments Corp. HRX Class II 1999-08-12
K992109 ENCORE FULLY COATED HIP Encore Orthopedics, Inc. LPH Class II 1999-08-12
K991889 ULTIMAX HAIG II NAIL SYSTEM Encore Orthopedics, Inc. LXT Class II 1999-08-12
K991678 WHITESIDE BIOMECHANICS SPINAL SYSTEM Whiteside Biomechanics, Inc. KWQ Class II 1999-08-12
K992346 KINEMATIC II ROTATING HINGE KNEE Howmedica Osteonics Corp. LGE Class II 1999-08-12
K991790 ULTIMAX ANKLE FUSION ROD SYSTEM Encore Orthopedics, Inc. HSB Class II 1999-08-06
K991877 MACMED PAEDIATRIC INTRAMEDULLARY NAIL Innervision, Inc. JDS Class II 1999-08-06
K991715 BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE Linvatec Corp. MAI Class II 1999-08-06
K992040 FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES Fiber Imaging Technologies, Inc. HRX Class II 1999-08-06
K990666 HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL Smith & Nephew, Inc. MEH Class II 1999-08-06
K991806 VHS SUPRACONDYLAR PLATE SYSTEM Walter Abendschein, M.D. KTT Class II 1999-08-06
K974728 INTER-OP METASUL ACETABULAR SYSTEM Sulzer Orthopedics, Inc. KWA Class III 1999-08-03
K991566 SOLUSTAPLE New Deal, S.A. JDR Class II 1999-08-03
K991581 NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO Zimmer, Inc. JWH Class II 1999-07-30
K991708 ZIRCONIA 22.22MM CERAMIC MODULAR HEADS Biomet, Inc. LZO Class II 1999-07-30
K991763 LACTOSORB HAND SYSTEM Biomet, Inc. HRS Class II 1999-07-30
K990770 BIORC ANCHOR Linvatec Corp. HWC Class II 1999-07-30
K982859 UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM Plus Orthopedics HRY Class II 1999-07-30
K984054 AGC V2 REVISION KNEE SYSTEM Biomet, Inc. JWH Class II 1999-07-30
K992344 OSTEONICS ACCP SYSTEM LINE EXTENSION Howmedica Osteonics Corp. KWQ Class II 1999-07-30
K992277 STAPLETAC BONE ANCHOR SYSTEM Influence, Inc. HWC Class II 1999-07-30
K992167 PERFORMANCE KNEE SYSTEM Biomet, Inc. JWH Class II 1999-07-28
K980070 OSTEONICS HA-COATED DEVICES Osteonics Corp. MEH Class II 1999-07-23
K991586 SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc. KWP Class II 1999-07-23
K991723 TRANSFX MULTI PIN CLAMP Immedica, Inc. LXT Class II 1999-07-22
K990524 E9000 SYSTEM Linvatec Corp. HRX Class II 1999-07-15
K991477 SPIN SNAP-OFF SCREW New Deal, S.A. HWC Class II 1999-07-14
K991622 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER Stelkast Company JDI Class II 1999-07-14
K991869 COBREX HIP STEM, MODEL 01-128-XXXXX Implex Corp. JDI Class II 1999-07-14
K991649 DEPUY ROCKWOOD CLAVICLE PIN Depuy, Inc. JDW Class II 1999-07-14
K990135 TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE Zimmer, Inc. LPH Class II 1999-07-12
K991485 SYNERGY POROUS SIZE 8 HIP STEM Smith & Nephew, Inc. LPH Class II 1999-07-12
K992065 GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD DePuy Orthopaedics, Inc. KWS Class II 1999-07-12
K990355 STAINLESS STEEL SOFT SUTURE WIRE Bregma International Trading Company , Ltd. LRN Class II 1999-07-08
K991807 TITANIUM LOW PROFILE SCREWS Biomet, Inc. LPH Class II 1999-07-08
K983837 HEDROCEL ACETABULAR CAGE SYSTEM Implex Corp. LPH Class II 1999-07-01
K990965 SYNTHES CERVIFIX SYSTEM Synthes (Usa) KWP Class II 1999-07-01
K992058 BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM Biomet, Inc. JDI Class II 1999-07-01
K990454 BIO-INTERFERENCE SCREW Innovasive Devices, Inc. HWC Class II 1999-07-01
K991603 GRIT BLASTED HUMERAL STEM Encore Orthopedics, Inc. KWT Class II 1999-06-29
K991952 OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS Howmedica Osteonics Corp. LZO Class II 1999-06-29
K991405 OMNI-FIX, HUMERAL NAIL Turnkey Intergration USA, Inc. KTW Class II 1999-06-29
K990057 SYNERGY ADJUSTABLE LENGTH ROD Interpore Cross Intl. MNI Class II 1999-06-28
K991987 COLOR BUFFED ANSWER CEMENTED FEMORAL Biomet, Inc. JDI Class II 1999-06-28
K991325 MODIFICATION OF ENCORE LINEAR POROUS COATED HIP Encore Orthopedics, Inc. LPH Class II 1999-06-25
K991064 METACARPAL FIXATION SYSTEM Medcanica, Inc. HTY Class II 1999-06-23
K991009 RC BUTTRESS Biomet, Inc. MAI Class II 1999-06-23
K991037 EUCLID REDUCTION AND GUIDANCE SYSTEM Modular Cutting Systems, Inc. JDS Class II 1999-06-23
K991143 MAGNA-ROM 21 KNEE SYSTEEM Sulzer Orthopedics, Inc. JWH Class II 1999-06-11
K991407 SYNTHES LOCKING CALCANEAL PLATES Synthes (Usa) LXT Class II 1999-06-11
K990183 IMPLEX ALUMINA FEMORAL HEAD Implex Corp. LZO Class II 1999-06-11
K991106 P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY DePuy Orthopaedics, Inc. JWH Class II 1999-06-09
K990911 MTP ARTHROPUMP DISPOSABLE TUBING SET Mtp Medical Technical Promotion GmbH HRX Class II 1999-06-03
K991538 OPERA CUPFLANGED ACETABULAR COMPONENTS Smith & Nephew, Inc., Orthopaedic Div. JDI Class II 1999-06-03

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