FDA Product Code
FDA Product Code KWP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3050
510(k) Clearances — 430 records · page 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K022070 | XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-07-22 | Special | PDF ↗ |
| K022015 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-07-18 | Special | PDF ↗ |
| K021170 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2002-07-09 | Traditional | PDF ↗ |
| K021919 | SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO | Ortho Tec, LLC | 2002-07-03 | Special | PDF ↗ |
| K021825 | MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM | Unitedstates Surgical | 2002-07-01 | Special | PDF ↗ |
| K021009 | OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM | Spinal Concepts, Inc. | 2002-06-18 | Traditional | PDF ↗ |
| K020709 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2002-05-09 | Special | PDF ↗ |
| K020134 | SPIRAL RADIUS 90-D RODDING SYSTEM | United States Surgical, A Division of Tyco Healthc | 2002-04-15 | Traditional | PDF ↗ |
| K014090 | ENDIUS SPINAL FIXATION SYSTEM | Endius, Inc. | 2002-03-11 | Traditional | PDF ↗ |
| K020426 | MSD WIRE SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-02-26 | Special | PDF ↗ |
| K020236 | MODIFICATION TO PASS SPINAL SYSTEM | Encore Orthopedics, Inc. | 2002-02-14 | Special | PDF ↗ |
| K013312 | P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) | Spine Vision, Inc. | 2002-02-13 | Traditional | PDF ↗ |
| K020155 | DYNA-LOK CLASSIC SPINAL SYSTEM | Medtronic Sofamor Danek | 2002-02-05 | Special | PDF ↗ |
| K013196 | ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM | Spinal Innovations, LLC | 2002-01-30 | Traditional | PDF ↗ |
| K014267 | BUTTERFLY PLATE FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-01-25 | Special | PDF ↗ |
| K013447 | ISOBAR SPINAL SYSTEM | Scien'Tx USA, Inc. | 2002-01-15 | Traditional | PDF ↗ |
| K013442 | PASS SPINAL SYSTEM | Encore Orthopedics, Inc. | 2002-01-15 | Traditional | PDF ↗ |
| K013823 | XIA SPINAL SYSTEM | Howmedica Osteonics Corp. | 2001-12-19 | Special | PDF ↗ |
| K012516 | EBI SPINELINK - II SPINAL FIXATION SYSTEM | Ebi, L.P. | 2001-11-27 | Traditional | PDF ↗ |
| K013441 | ISOLA POLYAXIAL WASHER | Depuyacromed | 2001-11-16 | Special | PDF ↗ |
| K012173 | DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM | Sulzer Spine-Tech | 2001-09-28 | Special | PDF ↗ |
| K003780 | VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek, Inc. | 2001-09-28 | Traditional | PDF ↗ |
| K012870 | XIA STAINLESS STEEL SYSTEM | Howmedica Osteonics Corp. | 2001-09-24 | Special | PDF ↗ |
| K012871 | SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177 | Interpore Cross Intl. | 2001-09-13 | Special | PDF ↗ |
| K011830 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2001-07-23 | Traditional | PDF ↗ |
| K011969 | SYNTHES CERVIFIX SYSTEM | Synthes (Usa) | 2001-07-19 | Special | PDF ↗ |
| K010681 | SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM | Depuyacromed | 2001-07-18 | Traditional | PDF ↗ |
| K003823 | SCS DT-02 TRANSVERSE CONNECTOR | Ortho Tec, LLC | 2001-07-11 | Special | PDF ↗ |
| K011508 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2001-06-12 | Special | PDF ↗ |
| K010181 | CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION | Medtronic Sofamor Danek, Inc. | 2001-06-12 | Traditional | PDF ↗ |
| K010632 | BUTTERFLY PLATE FUNCTION SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2001-05-31 | Traditional | PDF ↗ |
| K010515 | MODIFICATION TO SYNERGY SPINAL SYSTEM | Interpore Cross Intl. | 2001-03-22 | Special | PDF ↗ |
| K001535 | ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION | Ortho Tec, LLC | 2001-03-20 | Traditional | PDF ↗ |
| K003911 | TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE) | Terray Corp. | 2001-03-13 | Traditional | PDF ↗ |
| K003351 | PARSFIX CABLE-SCREW SYSTEM | Spinal Concepts, Inc. | 2001-01-24 | Traditional | PDF ↗ |
| K003822 | ISOLA CLOSED DUAL ROD CONNECTOR | Depuyacromed | 2001-01-08 | Special | PDF ↗ |
| K002733 | SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM | Depuyacromed | 2000-12-15 | Traditional | PDF ↗ |
| K002059 | AMT SPINAL SYSTEM | Micron Precision Engineering, Inc. | 2000-11-13 | Traditional | PDF ↗ |
| K002103 | SIMPLICITY SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2000-11-02 | Traditional | PDF ↗ |
| K002959 | MODIFICATION TO ISOBAR SPINAL SYSTEM | Encore Orthopedics, Inc. | 2000-10-16 | Special | PDF ↗ |
| K002082 | SPEEDLINK TRANSVERSE CONNECTOR | Spinal Concepts, Inc. | 2000-10-06 | Traditional | PDF ↗ |
| K002505 | XIA SPINE SYSTEM | Howmedica Osteonics Corp. | 2000-10-05 | Special | PDF ↗ |
| K002069 | ASCEND SPINAL FIXATION SYSTEM | Spinal Innovations, LLC | 2000-10-05 | Traditional | PDF ↗ |
| K002607 | MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS | Depuyacromed | 2000-09-12 | Special | PDF ↗ |
| K002517 | USS VAS | Synthes (Usa) | 2000-09-12 | Traditional | PDF ↗ |
| K001653 | XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY | Howmedica Osteonics Corp. | 2000-08-18 | Traditional | PDF ↗ |
| K001470 | E-Z LINK CROSS CONNECTOR | Depuyacromed | 2000-08-04 | Traditional | PDF ↗ |
| K001372 | E-Z LINK CROSS CONNECTOR | Depuyacromed | 2000-07-27 | Traditional | PDF ↗ |
| K001080 | SPINE SYSTEM EVOLUTION | Aesculap, Inc. | 2000-06-29 | Traditional | PDF ↗ |
| K001532 | DYNA-LOK CLASSIC SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2000-06-16 | Special | PDF ↗ |
| K001105 | MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS | Depuyacromed | 2000-04-24 | Special | PDF ↗ |
| K994187 | SYNTHES CERVIFIX SYSTEM | Synthes (Usa) | 1999-12-21 | Special | PDF ↗ |
| K992885 | VERSALOK LOW BACK FIXATION SYSTEM | Osteotech, Inc. | 1999-11-19 | Traditional | PDF ↗ |
| K993067 | SILHOUETTE SPINAL FIXATION SYSTEM | Sulzer Spine-Tech | 1999-11-16 | Special | PDF ↗ |
| K991662 | TITANIUM HARTSHILL SYSTEM | Surgicraft , Ltd. | 1999-11-08 | Traditional | PDF ↗ |
| K990986 | CONTOUR SPINAL SYSTEM | Ortho Development Corp. | 1999-10-14 | Traditional | PDF ↗ |
| K991198 | DYNA-LOK PLUS SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1999-08-27 | Traditional | PDF ↗ |
| K991089 | SYNTHES CERVIFIX SYSTEM | Synthes Spine | 1999-08-27 | Traditional | PDF ↗ |
| K991586 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | Osteotech, Inc. | 1999-07-23 | Traditional | PDF ↗ |
| K990965 | SYNTHES CERVIFIX SYSTEM | Synthes (Usa) | 1999-07-01 | Traditional | PDF ↗ |
| K990922 | OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR | Howmedica Osteonics Corp. | 1999-06-02 | Traditional | PDF ↗ |
| K984375 | OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY | Osteonics Corp. | 1999-04-30 | Traditional | PDF ↗ |
| K990303 | EBI OMEGA 21 SYSTEM | Electro-Biology, Inc. | 1999-04-29 | Traditional | PDF ↗ |
| K990845 | MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 | Advanced Spine Fixation Systems, Inc. | 1999-04-13 | Special | PDF ↗ |
| K990708 | TITANIUM VERSALOK | Wrightmedicaltechnologyinc | 1999-03-30 | Special | PDF ↗ |
| K981676 | CD HORIZON SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K984377 | SYNTHES SPINE CERVIFIX SYSTEM | Synthes (Usa) | 1999-01-21 | Traditional | PDF ↗ |
| K983904 | ROGOZINSKI SPINAL ROD SYSTEM | United States Surgical, A Division of Tyco Healthc | 1998-12-22 | Traditional | PDF ↗ |
| K983353 | SCS SPINAL SYSTEM | Orthotec, Inc. | 1998-12-18 | Traditional | PDF ↗ |
| K983530 | SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM | Synthes (Usa) | 1998-12-16 | Traditional | PDF ↗ |
| K983583 | DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS | Depuy, Inc. | 1998-12-03 | Traditional | PDF ↗ |
| K982322 | SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM | Synthes (Usa) | 1998-11-25 | Traditional | PDF ↗ |
| K983282 | OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 | Ohio Medical Instrument Co., Inc. | 1998-11-19 | Traditional | PDF ↗ |
| K983706 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM | Sofamor Danek USA,Inc. | 1998-11-12 | Special | PDF ↗ |
| K983197 | SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM) | United States Surgical, A Division of Tyco Healthc | 1998-10-26 | Traditional | PDF ↗ |
| K982490 | TENOR SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1998-10-05 | Traditional | PDF ↗ |
| K982320 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM | Depuy, Inc. | 1998-09-14 | Traditional | PDF ↗ |
| K982511 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS | Depuy, Inc. | 1998-09-14 | Traditional | PDF ↗ |
| K982494 | BWM SPINE SYSTEM | Howmedica Corp. | 1998-09-08 | Traditional | PDF ↗ |
| K982908 | MODIFICATION TO EBI SPINELINK SYSTEM | Electro-Biology, Inc. | 1998-08-28 | Special | PDF ↗ |
| K982011 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM | DePuy Orthopaedics, Inc. | 1998-08-06 | Traditional | PDF ↗ |
| K980288 | SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM | Spine-Tech, Inc. | 1998-07-29 | Traditional | PDF ↗ |
| K980121 | AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS | Aesculap, Inc. | 1998-06-10 | Traditional | PDF ↗ |
| K981452 | OSTEONICS LONG ARM CONTAINMENT RING | Osteonics Corp. | 1998-05-20 | Traditional | PDF ↗ |
| K980928 | SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM | Synthes Spine | 1998-05-11 | Traditional | PDF ↗ |
| K980358 | SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM | Synthes (Usa) | 1998-04-16 | Traditional | PDF ↗ |
| K974573 | DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM | Depuy, Inc. | 1998-02-18 | Traditional | PDF ↗ |
| K973868 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | Osteotech, Inc. | 1998-01-08 | Traditional | PDF ↗ |
| K964159 | CD SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1997-10-16 | Traditional | PDF ↗ |
| K965221 | RANSFORD CERVICAL FIXATION SYSTEM | Surgicraft , Ltd. | 1997-08-07 | Traditional | PDF ↗ |
| K971457 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED | Arcan Orthopaedic Corp. | 1997-07-16 | Traditional | PDF ↗ |
| K971289 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | Osteotech, Inc. | 1997-06-18 | Traditional | PDF ↗ |
| K965224 | EMPOWER ANTERIOR DIRECT SCREWS | Smith & Nephew Richards, Inc. | 1997-05-08 | Traditional | PDF ↗ |
| K964254 | TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1997-04-21 | Traditional | PDF ↗ |
| K964024 | DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM | Depuy, Inc. | 1997-03-26 | Traditional | PDF ↗ |
| K964404 | BACFIX SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 1997-03-26 | Traditional | PDF ↗ |
| K962628 | MOSS MIAMI SPINAL SYSTEM | Depuy, Inc. | 1997-03-18 | Traditional | PDF ↗ |
| K965145 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM | Depuy, Inc. | 1997-03-13 | Traditional | PDF ↗ |
| K962708 | TITANIUM CD HORIZON SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1997-02-06 | Traditional | PDF ↗ |
| K960444 | FINN ROD TO ROD CONNECTOR | Smith & Nephew Richards, Inc. | 1997-01-24 | Traditional | PDF ↗ |
Product code KWP · Class II · Orthopedic. Data: openFDA.