Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 33
- Latest Decision
- 2001-06-27
Clearances · page 123 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K011697 | EBI XFIX ACCESS PELVIC FIXATOR | Ebi, L.P. | KTT | Class II | 2001-06-27 |
| K011299 | SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR | Smith & Nephew, Inc. | MAI | Class II | 2001-06-27 |
| K010943 | SYNTHES STERNAL FIXATION SYSTEM | Synthes (Usa) | JDQ | Class II | 2001-06-27 |
| K010884 | TITANIUM COMPRESSION ANCHOR SYSTEM | Anchor Medical Technologies | HWC | Class II | 2001-06-20 |
| K010987 | KSEA MINIATURE TELESCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | HRX | Class II | 2001-06-19 |
| K011137 | RESORBABLE HAMMERTOE PIN | Biomet, Inc. | JDW | Class II | 2001-06-19 |
| K010847 | K'FIX | Avanta Orthopaedics, Inc. | NDL | Class II | 2001-06-19 |
| K010901 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B | Disc-O-Tech Medical Technologies, Ltd. | HSB | Class II | 2001-06-19 |
| K011172 | ARTHREX BIO-TRANSFIX | Arthrex, Inc. | MNU | Class II | 2001-06-19 |
| K011819 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | KWI | Class II | 2001-06-19 |
| K010988 | FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | HSB | Class II | 2001-06-19 |
| K003026 | PFC SIGMA LUGGED TIBIAL TRAY | DePuy Orthopaedics, Inc. | JWH | Class II | 2001-06-19 |
| K011567 | TORNIER TOTAL ELBOW PROSTHESIS | Tornier | JDB | Class II | 2001-06-19 |
| K011622 | OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS | Howmedica Osteonics Corp. | HSB | Class II | 2001-06-15 |
| K011367 | EXCEL FRACTURE CEMENTED HIP STEM | DePuy Orthopaedics, Inc. | JDI | Class II | 2001-06-15 |
| K011623 | EXETER HIP SYSTEM WITH V40 TAPER | Howmedica Osteonics Corp. | JDI | Class II | 2001-06-15 |
| K011262 | MODIFICATION TO THE BOLD SCREW | New Deal, S.A. | HWC | Class II | 2001-06-15 |
| K011795 | WORLAND UNICONDYLAR TIBIAL BEARING | Biomet, Inc. | HRY | Class II | 2001-06-13 |
| K010983 | PLLA PIN | Bionx Implants, Inc. | HTY | Class II | 2001-06-13 |
| K011509 | BARRETT UNICONDYLAR TIBIAL BEARING | Biomet, Inc. | HRY | Class II | 2001-06-13 |
| K002695 | MEMODYN STAPLE | Telos Medical Equipment | JDR | Class II | 2001-06-13 |
| K011508 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | KWP | Class II | 2001-06-12 |
| K010766 | SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE | Synthes (Usa) | KTT | Class II | 2001-06-12 |
| K011529 | T2 HUMERAL NAIL SYSTEM | Howmedica Osteonics Corp. | HSB | Class II | 2001-06-12 |
| K010181 | CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION | Medtronic Sofamor Danek, Inc. | KWP | Class II | 2001-06-12 |
| K011007 | TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 | Arthrex, Inc. | MBI | Class II | 2001-06-12 |
| K010780 | TROCHANTERIC NAIL | DePuy Orthopaedics, Inc. | HSB | Class II | 2001-06-12 |
| K010972 | ISOLA BAND CLAMP | Depuyacromed | MNI | Class II | 2001-06-12 |
| K011390 | BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | MBI | Class II | 2001-06-06 |
| K010922 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | MNI | Class II | 2001-06-06 |
| K011437 | SYNERGY 4.0 MM, 4.5 MM VLS SCREWS | Interpore Cross Intl. | MNI | Class II | 2001-06-06 |
| K010545 | TBW | Tri-Med, Inc. | NDL | Class II | 2001-06-06 |
| K010903 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | MNI | Class II | 2001-06-06 |
| K010108 | USS-LINE EXTENSION | Synthes | MNI | Class II | 2001-06-06 |
| K011029 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | MNI | Class II | 2001-06-05 |
| K010658 | MODIFIED USS FRACTURE SYSTEM | Synthes (Usa) | MNI | Class II | 2001-06-04 |
| K010632 | BUTTERFLY PLATE FUNCTION SYSTEM | Medtronic Sofamor Danek USA, Inc. | KWP | Class II | 2001-05-31 |
| K010639 | CONVERGENCE CERVICAL SPINAL SYSTEM | Spinal Innovations, LLC | KWQ | Class II | 2001-05-30 |
| K010811 | PERC-D SPINEWAND | Arthrocare Corp. | HRX | Class II | 2001-05-30 |
| K010783 | 2.0/2.4 CANNULATED SCREW SYSTEM | Osteomed Corp. | HWC | Class II | 2001-05-30 |
| K003033 | SCAPHIX, STAPLE, FIXATION, BONE | Avanta Orthopaedics, Inc. | JDR | Class II | 2001-05-30 |
| K003788 | SYNTHES RESORABLE MESHES AND SHEETS | Synthes (Usa) | HRS | Class II | 2001-05-30 |
| K010594 | DJ ORTHOPEDICS POST SCREW | Dj Orthopedics, LLC | HWC | Class II | 2001-05-29 |
| K003836 | SYNTHES SYNEX SPACER SYSTEM | Synthes | MQP | Class II | 2001-05-29 |
| K003733 | SCS CLOSED SCREW | Ortho Tec, LLC | MNH | Class II | 2001-05-29 |
| K010554 | MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A | Bionx Implants, Inc. | HWC | Class II | 2001-05-25 |
| K010563 | END-TO-END AND SIDE-BY-SIDE CONNECTORS | Spinal Concepts, Inc. | MNI | Class II | 2001-05-25 |
| K010557 | JAX GRANULES BONE VOID FILLER | Smith & Nephew, Inc. | MQV | Class II | 2001-05-25 |
| K011288 | TC-PLUS POROUS TIBIAL COMPONENTS | Plus Orthopedics | JWH | Class II | 2001-05-24 |
| K011258 | TC-PLUS POROUS FEMORAL COMPONENTS | Plus Orthopedics | JWH | Class II | 2001-05-24 |
| K010525 | ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM | Arthrex, Inc. | HWC | Class II | 2001-05-23 |
| K011237 | LACTOSORB PLATES, MESHES, AND PANELS/SHEETS | Biomet, Inc. | HRS | Class II | 2001-05-23 |
| K003618 | WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 | Whiteside Biomechanics, Inc. | NDD | Class II | 2001-05-23 |
| K010576 | MONARCH SPINE SYSTEM | Depuyacromed | MNI | Class II | 2001-05-23 |
| K010518 | SYNTHES ANTEROLATERAL CALCANEAL PLATE | Synthes (Usa) | KTT | Class II | 2001-05-23 |
| K011219 | ASCENT KNEE SYSTEM | Biomet, Inc. | JWH | Class II | 2001-05-18 |
| K010551 | EBI DYNAFIX VS OSTEOTOMY SYSTEM | Ebi, L.P. | NDF | Class II | 2001-05-17 |
| K010101 | GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM | Kinamed, Inc. | JWH | Class II | 2001-05-17 |
| K011218 | ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 | Exactech, Inc. | JDI | Class II | 2001-05-16 |
| K010466 | TETHER ACFS | Theken Surgical,Llc | KWQ | Class II | 2001-05-16 |
| K011182 | MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS | Depuyacromed | MNH | Class II | 2001-05-16 |
| K010457 | ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924 | Arthrex, Inc. | MBI | Class II | 2001-05-14 |
| K003504 | RT-PLUS MODULAR CEMENTED KNEE COMPONENTS | Plus Orthopedics | KRO | Class II | 2001-05-11 |
| K010633 | RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM | Mitek Products | HWC | Class II | 2001-05-09 |
| K003043 | SURGICAL TITANIUM MESH SYSTEM | Depuyacromed | MQP | Class II | 2001-05-08 |
| K002824 | MACS MODULAR ANTERIOR CONSTRUCT SYSTEM | Aesculap, Inc. | KWQ | Class II | 2001-05-08 |
| K010369 | CLARIS PLATE SYSTEM | Ortho Tec, LLC | MNH | Class II | 2001-05-08 |
| K003735 | BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR | Blackstone Medical, Inc. | MNI | Class II | 2001-05-08 |
| K010479 | MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR | Bonutti Research, Inc. | HTY | Class II | 2001-05-08 |
| K010595 | DJ ORTHOPEDICS INTERFERENCE SCREW | Dj Orthopedics, LLC | HWC | Class II | 2001-05-08 |
| K010677 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | HRX | Class II | 2001-05-07 |
| K011136 | APEX FIXATION PINS | Howmedica Osteonics Corp. | JDW | Class II | 2001-05-04 |
| K011067 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | MNI | Class II | 2001-05-04 |
| K010344 | ADJUSTABLE LARGE FIXATOR SYSTEM | Synthes (Usa) | KTT | Class II | 2001-05-03 |
| K010321 | MODULAR FOOT SYSTEM - 2.7 MM MODULE | Synthes (Usa) | KTW | Class II | 2001-05-02 |
| K010322 | ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) | Orthodyne, Inc. | HSB | Class II | 2001-05-02 |
| K003740 | MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION | Aesculap, Inc. | HRX | Class II | 2001-04-27 |
| K010529 | TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA | Medtronic Sofamor Danek USA, Inc. | JDI | Class II | 2001-04-27 |
| K003077 | SMARTSCREW MODEL 222006...227510 | Bionx Implants, Ltd. | HWC | Class II | 2001-04-26 |
| K011081 | ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS | Exactech, Inc. | LPH | Class II | 2001-04-24 |
| K003275 | SYNTHES SYNMESH SPACER SYSTEM | Synthes (Usa) | MQP | Class II | 2001-04-23 |
| K010810 | DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS | DePuy Orthopaedics, Inc. | HRY | Class II | 2001-04-18 |
| K010839 | CLS VARUS STEM/CLS 135 STEM | Sulzer Orthopedics, Inc. | LZO | Class II | 2001-04-18 |
| K010170 | TRIDENT POROUS TITANIUM ACETABULAR COMPONENT | Howmedica Osteonics Corp. | LPH | Class II | 2001-04-18 |
| K010845 | MODIFICATION TO OSTEONICS SPINAL SYSTEM | Howmedica Osteonics Corp. | MNH | Class II | 2001-04-18 |
| K010149 | WUJIN #3 FEMORAL NAIL | Biopro, Inc. | HSB | Class II | 2001-04-17 |
| K010115 | REFLEX ANTERIOR CERVICAL PLATE SYSTEM | Howmedica Osteonics Corp. | KWQ | Class II | 2001-04-16 |
| K010774 | AVL HINGE KNEE SYSTEM | Biomet, Inc. | KRO | Class II | 2001-04-13 |
| K010742 | MOSS MIAMI 5.5MM TITANIUM PIN NUT | Depuyacromed | MNH | Class II | 2001-04-12 |
| K010720 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | MNH | Class II | 2001-04-11 |
| K010786 | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | KXE | Class II | 2001-04-11 |
| K003463 | SOCON SPINAL SYSTEM | Aesculap, Inc. | MNH | Class II | 2001-04-11 |
| K010757 | LFIT V40 FEMORAL HEAD COMPONENTS | Howmedica Osteonics Corp. | JDI | Class II | 2001-04-11 |
| K003527 | MODIFICATION TO SYNTHES (USA) POLYPIN | Synthes (Usa) | HTY | Class II | 2001-04-09 |
| K010100 | AVON PATELLO-FEMORAL JOINT PROSTHESIS | Howmedica Osteonics Corp. | KRR | Class II | 2001-04-06 |
| K010801 | T2 FEMORAL NAIL | Howmedica Osteonics Corp. | HSB | Class II | 2001-04-06 |
| K010171 | DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER | DePuy Orthopaedics, Inc. | LPH | Class II | 2001-04-06 |
| K003274 | LPC-PLUS ACETABULAR CUP | Plus Orthopedics | LZO | Class II | 2001-04-06 |
| K010776 | TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS | Corin USA | MNH | Class II | 2001-04-06 |
| K010124 | ARTHREX UNIVERS 30 SHOULDER PROSTHESIS | Arthrex, Inc. | KWS | Class II | 2001-04-06 |
17,115 clearances in the Orthopedic panel. Data: openFDA.