meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
34
Latest Decision
1990-04-23

Clearances · page 158 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K900926 TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) Howmedica Corp. LRN Class II 1990-04-23
K900438 MC2P ACETABULAR COMPONENT Osteonics Corp. JDI Class II 1990-04-18
K901505 ARTHROSCOPIC ELECTROSURGICAL PROBE Smith & Nephew Dyonics, Inc. HRX Class II 1990-04-18
K897178 DYNATRON 360 RANGE OF MOTION TESTING DEVICE Dynatronics Corp. KQX Class I 1990-04-18
K900257 MULLER TYPE ACETABULAR CUP Lima Intl. Corp. JDI Class II 1990-04-18
K900584 ALTA LAG SCREW AND COMPRESSION SCREW Howmedica Corp. KTT Class II 1990-04-18
K890989 DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR Origin Medsystems, Inc. KTT Class II 1990-04-05
K893201 BONE PLATE Karlin Technology, Inc. HRS Class II 1990-04-04
K893203 BONE SCREW Karlin Technology, Inc. JDR Class II 1990-04-04
K897155 MITEK ANCHOR(TM) Mitek Surgical Products, Inc. JDR Class II 1990-04-04
K900680 EFFNER ARTHROPERISCOPE/ARTHROSCOPE W/REMOV. OPTICS Effner, Inc. HRX Class II 1990-03-29
K900132 ACUFEX STERILE CANNULATED INTERFERENCE SCREW; Acufex Microsurgical, Inc. HWC Class II 1990-03-28
K901240 ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED Med-Tek Corp. JDI Class II 1990-03-26
K900836 OSTEONICS ECSI HIP STEM SERIES Osteonics Corp. JDI Class II 1990-03-21
K895296 SELBY II INSTRUMENTATION Advanced Spine Fixation KWP Class II 1990-03-20
K894904 KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL Kinamed, Inc. LZO Class II 1990-03-19
K900003 SYSTEM TEN MODEL 100 SURGICAL SYSTEM Advanced Osseous Technologies JDX Class II 1990-03-16
K896048 S-ROM/NOILES MARK 3 Joint Medical Products Corp. KRO Class II 1990-03-14
K895507 LINK GIEBEL BLADE PLATE SYSTEM Link America, Inc. KTT Class II 1990-03-13
K900891 MODIFIED AML + ACETABULAR CUP PROSTHESIS Depuy, Inc. JDI Class II 1990-03-12
K897134 CMW CEMENT PRESSURISATION SYSTEM Dentsply Intl. KIH Class I 1990-03-02
K896081 WHITESIDE ORTHOLOC MODULAR METAL-BACKED PATELLA Dow Corning Wright JWH Class II 1990-03-02
K896740 AXIAL AND OFFSET CROSSLINK PLATES Danek Medical, Inc. KWP Class II 1990-02-26
K896397 S-ROM(TM)/NOILES(TM) MARK 5 KNEE Joint Medical Products Corp. JWH Class II 1990-02-22
K900070 MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM Dyonics, Inc. HRX Class II 1990-02-16
K896580 UNI-POLAR HEAD Richards Medical Co., Inc. LZY Class II 1990-02-15
K896542 ADDITION TO THE CONTINUUM KNEE SYSTEM (CKS(TM)) Techmedica, Inc. JWH Class II 1990-02-15
K895639 MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR Zimmer, Inc. JWH Class II 1990-02-08
K896669 WEBER PERMALOCK Allo Pro Corp. LZO Class II 1990-02-06
K896856 MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS Osteonics Corp. HSX Class II 1990-02-06
K894403 PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT Howmedica Corp. JWH Class II 1990-02-02
K895035 TITANIUM MODULAR COLLARED HIP PROSTHESIS Depuy, Inc. JDI Class II 1990-01-31
K894937 SHAW KNEE MODULAR TIBIAL TRAY-POROUS Johnson & Johnson Professionals, Inc. JWH Class II 1990-01-31
K895036 TITANIUM MODULAR MODULAR COLLARLESS HIP Depuy, Inc. JDI Class II 1990-01-31
K896678 SILICONE PLUG Orthopedic Systems, Inc. HRX Class II 1990-01-30
K896603 HSC UNIT ROD Danek Medical, Inc. KWP Class II 1990-01-30
K896325 QUANTUM HIP STEM Depuy, Inc. JDI Class II 1990-01-29
K896637 ACCESS(TM), SOFTWARE RELEASE 4.11P Diasonics, Inc. LPH Class II 1990-01-22
K894283 COMPREHENSIVE SPINE MOTION ANALYZER Orthopedic Systems, Inc. KQX Class I 1990-01-19
K896257 LEINBACH HIP PROSTHESIS 3M Company KWY Class II 1990-01-19
K895120 BATEMAN UPF II HIP PROSTHESIS SYSTEM 3M Company KWY Class II 1990-01-11
K894982 ACE WIRE TENSION CLAMP Buckman Co., Inc. JEC Class II 1990-01-11
K895962 KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS Kirschner Medical Corp. JWH Class II 1990-01-09
K895711 ACUFEX INTERFERENCE SCREW, STERILE Acufex Microsurgical, Inc. HWC Class II 1990-01-09
K896614 S.A.F. ACETABULAR CUP WITH POROUS COATING Synergy Orthopaedics Intl., Inc. JDL Class III 1990-01-09
K896045 WHITESIDE ORTHOLOC MODULAR-C TOTAL KNEE SYSTEM Dow Corning Wright JWH Class II 1990-01-05
K892411 MENNEN BONE FIXATION DEVICE Dentsply Intl. JDQ Class II 1990-01-05
K896452 KINEMAX TIBIAL STEM EXTENSION Howmedica Corp. JWH Class II 1990-01-04
K890192 LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET Danek Medical, Inc. KWP Class II 1990-01-04
K895241 INTRAMEDULLARY HIP SCREW Richards Medical Co., Inc. KTT Class II 1990-01-04
K895587 CROSS MEDICAL PRODUCT PEDICLE AWL Cross Medical Products, Inc. HWJ Class I 1990-01-04
K896770 ARTHRODISTRACTOR Arthroplastics, Inc. HRX Class II 1990-01-02
K896416 DYONICS SHOULDER PORTAL SYSTEM Dyonics, Inc. HRX Class II 1990-01-02
K896105 EVOLUTION HIP SYSTEM Dow Corning Wright KWL Class II 1989-12-29
K895802 NON CONSTRAINED TOTAL SHOULDER SYSTEM Orthopaedic Medical Group, Inc. KWT Class II 1989-12-27
K896584 ARTHROSCOPIC TUBING SHEATH Origin Medsystems, Inc. HRX Class II 1989-12-27
K895636 DIMENSION REVISION TOTAL HIP SYSTEM Kirschner Medical Corp. JDI Class II 1989-12-14
K893136 SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY Dyonics, Inc. HRX Class II 1989-12-14
K895399 KIM MODULAR FEMORAL HIP PROSTHESIS Dow Corning Wright LZO Class II 1989-12-14
K884890 LORD L.F.R. TOTAL HIP SYSTEM Howmedica Corp. JDI Class II 1989-12-08
K894068 KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM Kirschner Medical Corp. HSX Class II 1989-12-08
K896601 EXACTECH BONE SCREW Exactech, Inc. HWC Class II 1989-12-06
K896538 DISPOSABLE 45 DEGREE SHAVER Bowen & Company, Inc. HRX Class II 1989-12-06
K895886 BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM Biopro, Inc. KWL Class II 1989-12-01
K896196 ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR Orthoconcept, Inc. HRX Class II 1989-12-01
K895157 S.A.F. ACETABULAR CUP Synergy Orthopaedics Intl., Inc. KWA Class III 1989-12-01
K893903 KRONAMAX KUBE Physicians Digital Co. KQX Class I 1989-11-29
K895389 DEPUY (TM) TRUE COMPRESSION SCREW Depuy, Inc. HWC Class II 1989-11-24
K895439 ACROMED BEADED SUBLAMINAR WIRE Acromed Corp. KWP Class II 1989-11-22
K895441 ACROMED BUTTON SPINAL WIRE Acromed Corp. KWP Class II 1989-11-22
K896266 VS22 HIP PROSTHESIS 3M Company KWY Class II 1989-11-22
K895413 ACROMED DOUBLE SUBLAMINAR WIRE Acromed Corp. KWP Class II 1989-11-22
K884824 TRICON-M TOTAL KNEE SYSTEM Richards Medical Co., Inc. MBV Class II 1989-11-21
K893040 ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG Orthomet, Inc. JWH Class II 1989-11-20
K896204 ZIRCONIA CERAMIC HEAD ADD'L SIZES Richards Medical Co., Inc. LZO Class II 1989-11-20
K894604 BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT Biopro, Inc. KXA Class II 1989-11-17
K895607 POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT Exactech, Inc. JDL Class III 1989-11-17
K894965 POROUS-COATED TITANIUM ACETABULAR CUP Dow Corning Wright JDL Class III 1989-11-17
K893380 QCR SYSTEM I AND QCR SYSTEM II Bremer Mfg. & Tool Co., Inc. LGH Class I 1989-11-16
K893377 RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS Richards Medical Co., Inc. HSB Class II 1989-11-16
K896044 CROSS CANCELLOUS BONE SCREW Buckman Co., Inc. HWC Class II 1989-11-09
K894990 DAVOL ARTHROSCOPY CANNULA Davol, Inc. HRX Class II 1989-11-08
K895766 ASNIS II GUIDED BONE SCREW Howmedica Corp. HWC Class II 1989-11-08
K893821 ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST. Kinamed, Inc. JDI Class II 1989-11-06
K890044 BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE Biopro, Inc. HRY Class II 1989-11-06
K895702 KDR ACETABULAR COMPONENT Osteonics Corp. LWJ Class II 1989-11-03
K895226 NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS 3M Company KWS Class II 1989-11-03
K893928 LEVTECH SMALL BONE PLATE Buckman Co., Inc. KTW Class II 1989-11-03
K890665 MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES Dyonics, Inc. HRX Class II 1989-11-03
K890902 BIOFIX* BIODEGRADABLE FIXATION ROD Davis & Geck, Inc. HTY Class II 1989-11-03
K894658 KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS Howmedica Corp. JWH Class II 1989-10-20
K894719 CYPRESS MEDICAL BONE SCREW & PLATES Cypress Medical Mfg., Inc. HWC Class II 1989-10-20
K895861 DELTA-TECH(TM) CAST REMOVAL SYSTEM Johnson & Johnson Professionals, Inc. LGH Class I 1989-10-19
K892644 BIOLOX CERAMIC BALL Allo Pro Corp. LZO Class II 1989-10-19
K894504 WHITESIDE ORTHOLOC M.A. TIBIAL BASE Dow Corning Wright JWH Class II 1989-10-17
K895685 SMALL JOINT HAND INSTRUMENTS Leonard Medical, Inc. HRX Class II 1989-10-16
K890331 FREEMAN TOTAL HIP SYSTEM RIDGED STEM Orthopedic Systems, Inc. LWJ Class II 1989-10-13
K890498 FREEMAN MODULAR HIP STEM RIDGED VERSION Orthopedic Systems, Inc. JDI Class II 1989-10-13
K894694 OMNIFIT CERAMIC MORSE TAPER HEAD Osteonics Corp. LZO Class II 1989-10-12
K894702 STUART CD UNIVERSAL ROD CONNECTOR CLAMPS Bio-Medical Prosthetics KWP Class II 1989-10-11

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