meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
25
Latest Decision
1997-11-03

Clearances · page 135 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K972893 PARTNERSHIP REVISION FEMORAL STEMS Howmedica Corp. LZO Class II 1997-11-03
K971730 DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM Depuy, Inc. KWQ Class II 1997-11-03
K972928 KERBOULL CROSS Howmedica, Inc. JDI Class II 1997-11-03
K973281 THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* United States Surgical, A Division of Tyco Healthc MAI Class II 1997-11-03
K973060 DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM Depuy, Inc. KWQ Class II 1997-11-03
K972863 DURATION STABILIZED UHMWPE KNEE COMPONENTS Howmedica Corp. JWH Class II 1997-10-29
K971649 KSEA ARTHROPUMP PLUS KARL STORZ Endoscopy-America, Inc. HRX Class II 1997-10-29
K972864 DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS Howmedica Corp. JWH Class II 1997-10-29
K963502 CSCO FOREHEAD FIXATION SYSTEM Howmedica Corp. MBI Class II 1997-10-28
K973098 COMPRESSION CERCLAGE GUNDOLF CCG-GF Plus Orthopedics JDQ Class II 1997-10-27
K973195 TOTAL PERFORMANCE SYSTEM SHAVER Stryker Endoscopy HRX Class II 1997-10-24
K971018 SMC ACETABULAR COMPONENT Signal Medical Corp. LPH Class II 1997-10-24
K972770 ADVANCE ULTRA-CONGRUENT TIBIAL INSERT Wrightmedicaltechnologyinc JWH Class II 1997-10-21
K972752 DURACON CONVERSION METAL BACKED PATELLA Howmedica Corp. JWH Class II 1997-10-21
K971883 SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM Synthes (Usa) KWQ Class II 1997-10-16
K964880 VARI-ANGLE HIP SCREW (VHS) SYSTEM Walter Abendschein, M.D. KTT Class II 1997-10-16
K973530 INFINTY DISTAL FEMORAL COMPONENT Wrightmedicaltechnologyinc LPH Class II 1997-10-16
K964159 CD SPINAL SYSTEM Sofamor Danek USA,Inc. KWP Class II 1997-10-16
K973017 SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP Synthes (Usa) KTT Class II 1997-10-16
K972792 DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS Howmedica Corp. JDI Class II 1997-10-16
K972691 ABC TOTAL ELBOW PROTHESIS Biomet, Inc. JDB Class II 1997-10-15
K972690 ZIRCONIA CERAMIC FEMORAL HEAD Zimmer, Inc. LZO Class II 1997-10-15
K972629 DEPUY AE TK2 HIP SCREW SYSTEM Depuy, Inc. KTT Class II 1997-10-09
K973015 MULTITAK SS SUTURE SYSTEM Bonutti Research MBI Class II 1997-10-09
K972622 STRAIGHT-IN BONE SCREW FIXATION SYSTEM Influence, Inc. MBI Class II 1997-10-09
K972641 DUAL OFFSET PERFECTA IMC HIP STEM Wrightmedicaltechnologyinc JDI Class II 1997-10-09
K972813 GAMMA LOCKING NAIL SYSTEM Howmedica Corp. HSB Class II 1997-10-09
K972811 HOWMEDICA FULLY THREADED SCREWS Howmedica Corp. HSB Class II 1997-10-06
K971056 MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION Wrightmedicaltechnologyinc HSB Class II 1997-10-03
K970912 LEIBINGER SELF-DRILLING SCREW Howmedica Leibinger, Inc. HWC Class II 1997-10-01
K972637 PRECEDENT REVISION HIP SYSTEM Sulzer Orthopedics, Inc. LZO Class II 1997-10-01
K971523 DISTALLY FIXED HIP STEM Sulzer Orthopedics, Inc. MEH Class II 1997-10-01
K972501 APOLLO REVISION/CONSTRAINED KNEE SYSTEM Sulzer Orthopedics, Inc. JWH Class II 1997-10-01
K972718 M-2 ANTERIOR PLATE SYSTEM Acromed Corp. KWQ Class II 1997-10-01
K972494 DEPUY DUPONT ABSORBABLE SET SCREW Depuy, Inc. HWC Class II 1997-10-01
K972626 ADVANCE KNEE SYSTEM Wrightmedicaltechnologyinc JWH Class II 1997-09-29
K972438 INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER Innovasive Devices, Inc. MBI Class II 1997-09-26
K972460 OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION) Osteonics Corp. JDI Class II 1997-09-25
K973204 OSTEO BOS SYSTEM IN STAINLESS STEEL Osteonics Corp. HRS Class II 1997-09-25
K972768 BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM Blackstone Medical, Inc. HRX Class II 1997-09-25
K972361 V40 ZIRCONIA FEMORAL HEADS Howmedica, Inc. LZO Class II 1997-09-23
K972692 MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL Zimmer, Inc. HSB Class II 1997-09-19
K972393 INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI) Sulzer Orthopedics, Inc. LPH Class II 1997-09-19
K972568 DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM Depuy, Inc. MNH Class II 1997-09-19
K972599 ACUFEX SCREW CANNULA Smith & Nephew Endoscopy, Inc. HWC Class II 1997-09-19
K970544 DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS Depuy, Inc. KYJ Class II 1997-09-12
K972435 ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM Johnson & Johnson Professionals, Inc. JDI Class II 1997-09-11
K972479 ALTA PLATING SYSTEM Howmedica Corp. HRS Class II 1997-09-11
K972323 OSTEO BOS SYSTEM Osteonics Corp. HRS Class II 1997-09-10
K972223 BONE PLATE WITH CABLES Pioneer Surgical Technology HRS Class II 1997-09-10
K972516 SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM Synthes (Usa) JDS Class II 1997-09-04
K972403 BTI CORTICAL BONE SCREWS Biodynamic Technologies, Inc. HWC Class II 1997-08-29
K972356 INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER Innovasive Devices, Inc. MBI Class II 1997-08-26
K972183 DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL Ace Medical Co. HSB Class II 1997-08-26
K971938 REPICCI II UNICONDYLAR KNEE Biomet, Inc. HRY Class II 1997-08-25
K972196 OSTEO ANATOMICAL BONE PLATES Osteonics Corp. HRS Class II 1997-08-25
K970675 HEADLOC CERAMIC HEAD Ortho Development Corp. LZO Class II 1997-08-22
K971970 EBI SPINELINK SYSTEM Electro-Biology, Inc. MNH Class II 1997-08-20
K971870 LACTOSORB TRAUMA PLATING SYSTEM Biomet, Inc. HRS Class II 1997-08-19
K970635 TITANIUM SPINAL ROD SYSTEM Smith & Nephew, Inc., Orthopaedic Div. KWQ Class II 1997-08-14
K970241 DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS Depuy, Inc. LPH Class II 1997-08-14
K972108 ALTA INTRAMEDULLARY ROD SYSTEM Howmedica Corp. HSB Class II 1997-08-12
K970511 DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES Smith & Nephew, Inc. HRX Class II 1997-08-12
K964444 QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM Rdh Medical HSB Class II 1997-08-11
K964431 ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) Biomet, Inc. LZO Class II 1997-08-11
K972327 METAGEN ACTIVELOCK CERCLAGE SYSTEM Pacific Materials and Interfaces JDQ Class II 1997-08-11
K972420 LORENZ PECTUS SUPPORT BAR Walter Lorenz Surgical, Inc. HRS Class II 1997-08-11
K971962 OSTEO KIRSCHNER WIRES Osteonics Corp. HTY Class II 1997-08-11
K971922 INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER Innovasive Devices, Inc. MBI Class II 1997-08-07
K965221 RANSFORD CERVICAL FIXATION SYSTEM Surgicraft , Ltd. KWP Class II 1997-08-07
K971890 RECOVERY PROTRUSIO CAGE Biomet, Inc. JDI Class II 1997-08-07
K971715 SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS Sulzer Orthopedics, Inc. KWS Class II 1997-08-07
K964616 QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT Whiteside Biomechanics, Inc. LPH Class II 1997-08-07
K971705 IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED Implex Corp. JDI Class II 1997-08-06
K972233 STRYKER WEDGE INTERFERENCE SCREW SYSTEM Stryker Endoscopy HWC Class II 1997-08-05
K964226 MEMORY STAPLE (20 SIZES AVAILABLE) Landos, Inc. JDR Class II 1997-08-05
K970048 SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS) Synthes (Usa) KWQ Class II 1997-08-01
K971770 APOLLO KNEE FEMORAL SPACERS Sulzer Orthopedics, Inc. JWH Class II 1997-07-31
K971996 MEDIVISION ARTHROSCOP Medivision Scope Service Center, Inc. HRX Class II 1997-07-31
K971800 OSTEO CANNULATED SCREW SYSTEM Osteonics Corp. HWC Class II 1997-07-30
K963780 DUAL ROD ANTERIOR FIXATOR SYSTEM Sofamor Danek USA,Inc. KWQ Class II 1997-07-30
K971723 FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) Arthrex, Inc. MBI Class II 1997-07-30
K971791 VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION Louisville Laboratories, Inc. MBI Class II 1997-07-30
K971721 WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD Whiteside Biomechanics, Inc. LZO Class II 1997-07-30
K971854 OSTEOLOCK ACETABULAR SHELL SYSTEM Howmedica Corp. LPH Class II 1997-07-30
K971752 ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER) Zimmer, Inc. LZO Class II 1997-07-30
K971802 VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION Louisville Laboratories, Inc. MBI Class II 1997-07-30
K971789 IMPLEX CONTINUUM POROUS PATELLAR Implex Corp. JWH Class II 1997-07-24
K971718 MICRO-SEAL ACETABULAR SYSTEM Whiteside Biomechanics, Inc. LPH Class II 1997-07-23
K965198 ULTIMA TPS CEMENTED STEM Johnson & Johnson International KWL Class II 1997-07-23
K971783 SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM Synthes (Usa) HTY Class II 1997-07-18
K971816 ATLAS FRACTURE PROXIMAL HUMERAL NAIL Biomet, Inc. HSB Class II 1997-07-18
K971581 HEMISPHERE CEMENTED CUP Ortho Development Corp. JDI Class II 1997-07-18
K971755 HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM Howmedica Corp. JEC Class II 1997-07-17
K971189 P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) Johnson & Johnson Professionals, Inc. JWH Class II 1997-07-17
K961719 EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES Howmedica Leibinger, Inc. HRS Class II 1997-07-17
K971457 BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED Arcan Orthopaedic Corp. KWP Class II 1997-07-16
K971652 P.F.C. SIGMA INSET PATELLA Johnson & Johnson Professionals, Inc. JWH Class II 1997-07-16
K971741 DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE Howmedica Corp. JDQ Class II 1997-07-16
K971497 OSTEONICS ANTEVERTED NECK HIP STEM Osteonics Corp. LZO Class II 1997-07-16

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