meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
35
Latest Decision
1986-01-21

Clearances · page 165 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K855031 MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P Advanced Biosearch Assn. HWC Class II 1986-01-21
K854827 LINK CORTICAL SCREWS Link America, Inc. HWC Class II 1985-12-27
K854826 LINK CANCELLOUS SCREWS Link America, Inc. HWC Class II 1985-12-27
K853916 P.M. HIP-FEMORAL PROSTHESIS Advanced Biosearch Assn. JDI Class II 1985-12-27
K852365 LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM Link America, Inc. KWS Class II 1985-12-16
K854554 DELTA-LITE CASTING RESIN Johnson & Johnson Professionals, Inc. LGF Class I 1985-12-11
K854524 KIRSCHNER SPINAL PRODUCT SYSTEM Kirschner Medical Corp. KWP Class II 1985-12-09
K853661 MILLAR/GALANTE PRECOATED TOTAL KNEE Zimmer, Inc. JWH Class II 1985-12-09
K854270 MURPHY ADJUSTABLE SPLINT Comfortex, Inc. KQZ Class I 1985-12-09
K854325 TRICON UNICOMPARTMENTAL KNEE SYSTEM Richards Medical Co., Inc. HSX Class II 1985-12-09
K854338 KIRSCHNER INTRAMEDULLARY NAIL SYSTEM Kirschner Medical Corp. HSB Class II 1985-12-09
K853869 TITANIUIM BONE SCREW George Tiemann & Co. HWC Class II 1985-12-09
K844050 ARTHOPOR-ACETABULAR COMPONENT Joint Medical Products Corp. JDI Class II 1985-12-06
K853886 P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM Howmedica Corp. JDI Class II 1985-11-25
K853020 POROCOAT SYNATOMIC UNICONDYLAR KNEE Depuy, Inc. HSX Class II 1985-11-25
K854341 DELTA-LITE CASTING RESIN Johnson & Johnson Professionals, Inc. LGF Class I 1985-11-22
K853524 APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT Intermedics Orthopedics KMC Class II 1985-11-22
K853795 KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD Kirschner Medical Corp. KWY Class II 1985-11-22
K854445 KIRSCHNER BONE FIXATION FASTENER SYSTEM Kirschner Medical Corp. JDR Class II 1985-11-19
K853768 MULLER SELF LOCKING TOTAL HIP Protek, Inc. JDI Class II 1985-11-19
K854046 CONICAL COLLAR HIP PROSTHESIS Kirschner Medical Corp. JDI Class II 1985-11-19
K854205 KIRSCHNER COMPRESSION HIP SCREW SYSTEM Kirschner Medical Corp. KTT Class II 1985-11-19
K853709 A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM Downs Surgical , Ltd. HRS Class II 1985-11-15
K853408 COLLAR LESS AML HIP Depuy, Inc. JDI Class II 1985-11-15
K854313 SONGER TITANIUM SPINE-L-ROD Ortho-Engineering Products Co. KWP Class II 1985-11-15
K853259 MALLORY/HEAD TOTAL HIP SYSTEM Biomet, Inc. KMC Class II 1985-11-01
K852839 FREEMAN HIP Advanced Biosearch Assn. JDI Class II 1985-10-29
K853169 GT HIP PROSTHESIS FEMORAL COMPONENT Intermedics Orthopedics JDI Class II 1985-10-29
K853438 H-H HUNTER ACTIVE TENDON IMPLANT Holter-Hausner Intl. HXA Class II 1985-09-30
K853662 MUELLER CURVED STEM HEMI-PROSTHESIS Protek, Inc. KWL Class II 1985-09-24
K853033 HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM A.W. Showell (Surgicraft) , Ltd. KWQ Class II 1985-09-24
K844319 KM-2 METAL-BACKED ACETABULAR CUP Kirschner Medical Corp. JDI Class II 1985-09-19
K853655 NEW JERSEY MODULAR FEMORAL HIP Depuy, Inc. JDI Class II 1985-09-19
K852517 CLS HIP PROSTHESIS Advanced Biosearch Assn. JDI Class II 1985-09-18
K851422 S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP Joint Medical Products Corp. JDI Class II 1985-09-18
K853310 SIMPLEX ENHANCEMENT MIXER Howmedica Corp. JDZ Class I 1985-09-11
K853267 DAY STAPLE Protek, Inc. JDR Class II 1985-09-06
K852699 FREEMAN ACETABULAR CUP Advanced Biosearch Assn. KWA Class III 1985-09-05
K853268 FREEMAN UNI-COMPARTMENTAL KNEE Protek, Inc. HSX Class II 1985-09-04
K852759 AMERICAN EDWARDS LABORATORIES FLEXISCOPE American Edwards Laboratories HRX Class II 1985-08-22
K852585 POROUS APF/MODULAR FEMORAL COMPONENT Biomet, Inc. JDI Class II 1985-08-22
K852198 AML PROXIMAL POROCOAT FEMORAL HIP Depuy, Inc. LPH Class II 1985-08-22
K852546 HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY Howmedica Corp. JDI Class II 1985-08-21
K844595 ORTHOPEDIC CUSTOM SURGICAL KIT Xanmed Corp. LXH Class I 1985-08-21
K852153 THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP Howmedica Corp. JDI Class II 1985-08-16
K852584 POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT Biomet, Inc. KWL Class II 1985-08-15
K852705 LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS Waldemar Link GmbH & Co. KG JDI Class II 1985-08-13
K852351 KIRSCHNER SELF-TAPPING ACETABULAR CUP Kirschner Medical Corp. KWA Class III 1985-08-09
K852592 CO2 FOR ARTHROSCOPY The Anspach Effort, Inc. HRX Class II 1985-08-09
K852397 EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129) Howmedica Corp. JEC Class II 1985-08-09
K844818 NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS Osteonics Corp. KWL Class II 1985-07-30
K851566 HOWMEDICA FEMORAL COMPONENT HIP SYS 6259 Howmedica Corp. JDG Class II 1985-07-30
K852390 CMT 1000 Prestigeline, Inc. KQX Class I 1985-07-19
K852059 THE P.C.A. DOME PATELLA COMPONENT Howmedica Corp. JWH Class II 1985-07-16
K851205 CEMENTRIFUGE Biodynamic Technologies, Inc. JDZ Class I 1985-07-16
K850413 MEC HIP BOLT Pfizer, Inc. KTT Class II 1985-07-15
K850403 MEC DISTAL FEMORAL BOLT Pfizer, Inc. KTT Class II 1985-07-15
K850443 MEC ROD CONNECTOR Pfizer, Inc. KTT Class II 1985-07-15
K850840 HOWMEDICA THREADED ACETABULAR COMPONENT Pfizer, Inc. KWA Class III 1985-07-15
K851341 SYNATOMIC VARIABLE FIT TIBIAL PLATEAU Depuy, Inc. KYK Class II 1985-07-15
K851786 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF Artiberia LGG Class I 1985-07-09
K851339 PRECISION HARVEST & INLAY INSTRUMENT SET Concept, Inc. HWK Class I 1985-07-02
K852563 PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONG The Huxley Instrument Corp. HTY Class II 1985-06-28
K852561 PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONG The Huxley Instrument Corp. HTY Class II 1985-06-28
K851919 SUPRACONDYLAR BONE PLATE Warsaw Orthopedic, Inc. KTT Class II 1985-06-28
K852562 PIN SET, BONE, RUSH, 4 THRU 10 1/2 INCHES LONG The Huxley Instrument Corp. HTY Class II 1985-06-28
K851414 SEGMENTAL SPINAL RODS Stuart KWQ Class II 1985-06-28
K851374 AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE American Edwards Laboratories HRX Class II 1985-06-28
K852420 BTM TOTAL HIP SYSTEM Kirschner Medical Corp. KWL Class II 1985-06-28
K852560 PINSET, BONE, RUSH 9-1/2 THRU 20-3/4 INCHES LONG The Huxley Instrument Corp. HTY Class II 1985-06-28
K844068 TROCHANTER CABLE GRIP SYSTEM Howmedica Corp. KTT Class II 1985-06-21
K851800 69-100 TO 69-114 VARIOUS CUTICLE SCISSORS Artiberia HRR Class I 1985-06-20
K852369 LIDGRER-LUND ACETABULAR SOCKETS Link America, Inc. JDL Class III 1985-06-18
K851404 OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES Osteonics Corp. KWA Class III 1985-06-18
K851881 ORTHOPEADIC CEMENT DELIVERY SYSTEM Dentsply Intl. KIH Class I 1985-06-13
K851935 EDWARDS SACRAL SCREW Zimmer, Inc. KWP Class II 1985-06-07
K851421 S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP Joint Medical Products Corp. LPH Class II 1985-06-04
K843940 LINK CEMENTLESS SCREW-IN ACETABULAR CUP Waldemar Link GmbH & Co. KG KWA Class III 1985-06-03
K843950 LINK CEMENTLESS SCREW-IN ACETABULAR CUP Waldemar Link GmbH & Co. KG KWA Class III 1985-06-03
K851349 LERE NAIL & PLATE COMBIN. ONE PIECE FORGED Medicalex KTW Class II 1985-05-29
K850039 HALIFAX SPINAL CLAMP Levtech, Inc. KWP Class II 1985-05-29
K850928 V.E.P. HIP -VARIABLE ENDO-PROSTHESIS Unitas Ent. KWL Class II 1985-05-28
K851213 ZWEYMULLER CUP Allo Pro Corp. KWA Class III 1985-05-28
K852026 FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER Warsaw Orthopedic, Inc. HWC Class II 1985-05-22
K852020 INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI Warsaw Orthopedic, Inc. HSB Class II 1985-05-22
K851231 RMC POSTERIOR STABILIZED KNEE SYSTEM Richards Medical Co., Inc. JWH Class II 1985-05-22
K851229 CODMAN ARTHROSCOPE Codman & Shurtleff, Inc. HRX Class II 1985-05-22
K850024 ORTHOPEDIC IMPLANT SCREWS Kirkstil Corp., Inc. HWC Class II 1985-05-20
K850026 ORTHOPEDIC IMPLANT NAILS & PINS Kirkstil Corp., Inc. HTY Class II 1985-05-20
K850025 ORTHOPEDIC IMPLANT PLATES Kirkstil Corp., Inc. HRS Class II 1985-05-20
K850697 DIGITAL GRIP/PINCH STRENGTH METOR Chattanooga Group, Inc. LBB Class II 1985-05-14
K850793 MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA Intermedics Orthopedics JDL Class III 1985-05-09
K850773 PM CEMENTLESS SCREW-IN ACETABULAR CUP Advanced Biosearch Assn. KWA Class III 1985-05-02
K850766 ZIMMER THREADED ACETABULAR CUP Zimmer, Inc. KWA Class III 1985-05-01
K850631 KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES Kirschner Medical Corp. JDQ Class II 1985-05-01
K850352 MICRO-STRUC. ACETABULAR COMPON- MC2P Osteonics Corp. JDL Class III 1985-04-25
K843995 TF-II HIP PROSTHESIS Dow Corning Corp. Healthcare Industries Materials KWL Class II 1985-04-23
K850055 PROFILE FEMORAL HIP Depuy, Inc. KWA Class III 1985-04-23
K851214 T-SCREW Northeast Iowa Podiatry HWC Class II 1985-04-22
K845025 AUSTIN-MOORE MODULAR HIP PROSTHESIS Biomet, Inc. KWL Class II 1985-04-19

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