FDA Product Code
FDA Product Code MNI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3070
510(k) Clearances — 303 records · page 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K033508 | PLUS PIVOT LINK UNIVERSAL SYSTEM | Spine Vision, Inc. | 2004-01-27 | Traditional | PDF ↗ |
| K022908 | POSTERIOR CABLE SCREW | Pioneer Surgical Technology | 2004-01-22 | Traditional | PDF ↗ |
| K032219 | REVOLUTION SPINAL FIXATION SYSTEM | Spinal Innovations, Inc. | 2003-12-19 | Traditional | PDF ↗ |
| K033495 | MODIFICATION TO EQUATION FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2003-12-03 | Special | PDF ↗ |
| K030958 | ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS | Ortho Tec, LLC | 2003-11-20 | Traditional | PDF ↗ |
| K032739 | UCR SPINAL SYSTEM | Seaspine | 2003-11-20 | Special | PDF ↗ |
| K033271 | DYNALOK CLASSIC SPINAL SYSTEM | Medtronic Sofamor Danek | 2003-11-06 | Special | PDF ↗ |
| K032398 | PLUS PIVOT LINK UNIVERSAL SYSTEM | Spine Vision, Inc. | 2003-10-31 | Traditional | PDF ↗ |
| K031455 | CONKLUSION PEDICLE SCREW SYSTEM | Signus Medical, LLC | 2003-10-22 | Traditional | PDF ↗ |
| K031967 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2003-09-17 | Traditional | PDF ↗ |
| K032578 | TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2003-09-17 | Special | PDF ↗ |
| K031985 | SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 2003-09-11 | Traditional | PDF ↗ |
| K032037 | CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) | Medtronic Sofamor Danek | 2003-09-04 | Traditional | PDF ↗ |
| K031833 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2003-09-03 | Special | PDF ↗ |
| K024313 | MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM | Pisharodi Surgicals, Inc. | 2003-08-29 | Special | PDF ↗ |
| K031354 | EBI OMEGA21 SPINAL FIXATION SYSTEM | Ebi, L.P. | 2003-08-06 | Traditional | PDF ↗ |
| K031381 | UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS | Seaspine | 2003-07-30 | Traditional | PDF ↗ |
| K031888 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2003-06-27 | Special | PDF ↗ |
| K031655 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2003-06-27 | Special | PDF ↗ |
| K030932 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2003-05-16 | Special | PDF ↗ |
| K030840 | MODIFICATION TO HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2003-05-15 | Special | PDF ↗ |
| K030862 | BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR | Blackstone Medical, Inc. | 2003-04-17 | Special | PDF ↗ |
| K022949 | SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS | Synthes (Usa) | 2003-03-24 | Traditional | PDF ↗ |
| K024096 | OPTIMA, SPINAL SYSTEM | U&I Corp., America | 2003-03-12 | Traditional | PDF ↗ |
| K030377 | MODIFICATION TO SYNTHES CERVIFIX SYSTEM | Synthes (Usa) | 2003-03-06 | Special | PDF ↗ |
| K030103 | SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS | Depuyacromed | 2003-02-05 | Special | PDF ↗ |
| K023299 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM | Alphatec Mfg., Inc. | 2002-12-11 | Traditional | PDF ↗ |
| K023644 | MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 2002-11-25 | Special | PDF ↗ |
| K022768 | AMT POLYAXIAL PEDICLE SCREW | Micron Precision Engineering, Inc. | 2002-11-13 | Traditional | PDF ↗ |
| K022271 | PLUS PIVOT LINK UNIVERSAL SYSTEM | Spine Vision, Inc. | 2002-09-23 | Traditional | PDF ↗ |
| K022778 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-09-18 | Special | PDF ↗ |
| K022285 | MODIFICATION TO ISOLA SPINAL SYSTEM | Depuyacromed | 2002-08-13 | Special | PDF ↗ |
| K022160 | XIA SPINAL SYSTEM | Howmedica Osteonics | 2002-08-01 | Special | PDF ↗ |
| K021510 | UNI-T UNI-THREAD SPINAL SYSTEM | Spine Vision, Inc. | 2002-08-01 | Traditional | PDF ↗ |
| K022190 | MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM | Depuyacromed | 2002-07-24 | Special | PDF ↗ |
| K021275 | MICOMED POSTERIOR DOUBLEROD SYSTEM | Micomed Ortho GmbH | 2002-07-18 | Traditional | PDF ↗ |
| K020279 | FOREX CORPORATION, OPTIMA, SPINAL SYSTEM | Forex Corp. | 2002-06-20 | Traditional | PDF ↗ |
| K021379 | SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 | Ortho Tec, LLC | 2002-05-31 | Special | PDF ↗ |
| K021106 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-05-03 | Special | PDF ↗ |
| K020517 | SYNTHES DUAL-OPENING USS | Synthes (Usa) | 2002-04-15 | Special | PDF ↗ |
| K013301 | UNI-T SPINAL SYSTEM | Spine Vision, Inc. | 2002-02-13 | Traditional | PDF ↗ |
| K013885 | BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS | Blackstone Medical, Inc. | 2002-02-01 | Traditional | PDF ↗ |
| K013440 | ISOBAR SPINAL SYSTEM | Scien'Tx USA, Inc. | 2001-11-16 | Special | PDF ↗ |
| K013431 | PASS SPINAL SYSTEM | Encore Orthopedics, Inc. | 2001-11-15 | Special | PDF ↗ |
| K013403 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2001-11-14 | Special | PDF ↗ |
| K013222 | SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM | Depuyacromed | 2001-11-07 | Traditional | PDF ↗ |
| K013191 | PASS SPINAL SYSTEM | Encore Orthopedics, Inc. | 2001-10-24 | Special | PDF ↗ |
| K011807 | SCS CLARIS SPINAL SCREWS, TYPES V,G,E | Ortho Tec, LLC | 2001-08-07 | Special | PDF ↗ |
| K012175 | PASS SPINAL SYSTEM | Encore Orthopedics, Inc. | 2001-07-31 | Special | PDF ↗ |
| K010972 | ISOLA BAND CLAMP | Depuyacromed | 2001-06-12 | Special | PDF ↗ |
| K010903 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2001-06-06 | Traditional | PDF ↗ |
| K011437 | SYNERGY 4.0 MM, 4.5 MM VLS SCREWS | Interpore Cross Intl. | 2001-06-06 | Special | PDF ↗ |
| K010108 | USS-LINE EXTENSION | Synthes | 2001-06-06 | Traditional | PDF ↗ |
| K010922 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2001-06-06 | Traditional | PDF ↗ |
| K011029 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2001-06-05 | Special | PDF ↗ |
| K010658 | MODIFIED USS FRACTURE SYSTEM | Synthes (Usa) | 2001-06-04 | Traditional | PDF ↗ |
| K010563 | END-TO-END AND SIDE-BY-SIDE CONNECTORS | Spinal Concepts, Inc. | 2001-05-25 | Traditional | PDF ↗ |
| K010576 | MONARCH SPINE SYSTEM | Depuyacromed | 2001-05-23 | Traditional | PDF ↗ |
| K003735 | BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR | Blackstone Medical, Inc. | 2001-05-08 | Traditional | PDF ↗ |
| K011067 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2001-05-04 | Special | PDF ↗ |
| K994121 | SMALL STATURE USS | Synthes (Usa) | 2000-10-17 | Traditional | PDF ↗ |
| K000766 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2000-06-01 | Traditional | PDF ↗ |
| K000965 | MULTI-AXIAL CROSS (MAC) CONNECTOR | Howmedica Osteonics Corp. | 2000-05-11 | Special | PDF ↗ |
| K000991 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2000-04-18 | Special | PDF ↗ |
| K000876 | SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP | Interpore Cross Intl. | 2000-04-18 | Special | PDF ↗ |
| K001037 | MODIFICATION TO EBI SPINELINK SYSTEM | Ebi, L.P. | 2000-04-14 | Special | PDF ↗ |
| K000450 | MODIFICATION TO SYNTHES USS | Synthes Spine | 2000-03-10 | Special | PDF ↗ |
| K000425 | ISOBAR SPINAL SYSTEM | Encore Orthopedics, Inc. | 2000-03-07 | Special | PDF ↗ |
| K992147 | TRIPLE-FIX SPINAL FIXATION SYSTEM | Advanced Spine Technology, Inc. | 2000-02-28 | Traditional | PDF ↗ |
| K000236 | SYNERGY VLS CAP NUT MODELS 2206, 6102 | Interpore Cross Intl. | 2000-02-16 | Special | PDF ↗ |
| K991862 | MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS) | Micomed GmbH | 2000-01-13 | Traditional | PDF ↗ |
| K993402 | OPUS SPINAL SYSTEM | Howmedica Osteonics Corp. | 1999-12-20 | Traditional | PDF ↗ |
| K992920 | EBI SPINELINK SYSTEM | Ebi, L.P. | 1999-11-23 | Traditional | PDF ↗ |
| K992738 | ISOBAR SPINAL SYSTEM | Encore Orthopedics, Inc. | 1999-11-08 | Traditional | PDF ↗ |
| K991326 | ISOBAR SEMI-RIGID SPINAL SYSTEM | Scien'Tx USA, Inc. | 1999-11-08 | Traditional | PDF ↗ |
| K992369 | SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22 | Interpore Cross Intl. | 1999-10-13 | Traditional | PDF ↗ |
| K992333 | EBI OMEGA 21 SYSTEM | Electro-Biology, Inc. | 1999-10-08 | Traditional | PDF ↗ |
| K992276 | MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM | Sulzer Spine-Tech | 1999-10-01 | Traditional | PDF ↗ |
| K992928 | CD HORIZON SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1999-09-21 | Special | PDF ↗ |
| K991721 | EBI OMEGA 21 SYSTEM | Ebi Electro Biology | 1999-08-13 | Traditional | PDF ↗ |
| K990057 | SYNERGY ADJUSTABLE LENGTH ROD | Interpore Cross Intl. | 1999-06-28 | Traditional | PDF ↗ |
| K990745 | MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM | Synthes Spine | 1999-03-30 | Special | PDF ↗ |
| K984578 | SYNERGY D2 SPINAL IMPLANTS | Interpore Cross Intl. | 1999-03-23 | Traditional | PDF ↗ |
| K990158 | OSTEONICS COMBINATION SCREW RING/BLOCKER | Osteonics Corp. | 1999-02-01 | Special | PDF ↗ |
| K990059 | OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS | Howmedica Osteonics Corp. | 1999-01-28 | Traditional | PDF ↗ |
| K984350 | VSP SYSTEM | Depuy Motech Acromed | 1999-01-20 | Traditional | PDF ↗ |
| K984348 | TIMX LOW BACK SYSTEM | Depuy Motech Acromed | 1999-01-20 | Traditional | PDF ↗ |
| K984612 | SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM | Synthes Spine | 1999-01-19 | Special | PDF ↗ |
| K984027 | EBI SPINELINK SYSTEM | Electro-Biology, Inc. | 1999-01-19 | Traditional | PDF ↗ |
| K984522 | MODIFICATION OF TSRH SPINAL SYSTEM | Danek Medical, Inc. | 1999-01-06 | Special | PDF ↗ |
| K984378 | DEPUY ACROMED MOSS SPINAL SYSTEM | Depuy, Inc. | 1998-12-30 | Traditional | PDF ↗ |
| K980184 | CD SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1998-12-18 | Traditional | PDF ↗ |
| K983672 | DYNA-LOK SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1998-12-16 | Traditional | PDF ↗ |
| K983260 | MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 1998-10-21 | Traditional | PDF ↗ |
| K982987 | SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM | Synthes Spine | 1998-10-21 | Traditional | PDF ↗ |
| K983258 | MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 1998-10-21 | Traditional | PDF ↗ |
| K980485 | ISOLA SPINAL SYSTEM | Acromed Corp. | 1998-10-21 | Traditional | PDF ↗ |
| K982990 | TSRH SPINAL SYSTEM | Sofamor Danek USA,Inc. | 1998-10-21 | Traditional | PDF ↗ |
| K980484 | AESCULAP SPINE SYSTEM EVOLUTION | Aesculap, Inc. | 1998-10-02 | Traditional | PDF ↗ |
| K982914 | AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS | Aesculap, Inc. | 1998-10-02 | Traditional | PDF ↗ |
Product code MNI · Class II · Orthopedic. Data: openFDA.