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 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K080394 | BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM | Blackstone Medical, Inc. | 2008-03-13 | Special | PDF ↗ |
| K073420 | BLACKSTONE ASCENT MULTIAXIAL SCREWS | Blackstone Medical, Inc. | 2008-02-14 | Special | PDF ↗ |
| K073654 | BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR | Blackstone Medical, Inc. | 2008-01-24 | Special | PDF ↗ |
| K072866 | ISSYS LP SPINAL FIXATION SYSTEM | Custom Spine, Inc. | 2007-12-13 | Traditional | PDF ↗ |
| K071942 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2007-12-11 | Traditional | PDF ↗ |
| K072081 | ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM | Alphatec Spine, Inc. | 2007-10-24 | Traditional | PDF ↗ |
| K062447 | TRAVERSE OCT SPINAL FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2007-10-15 | Traditional | PDF ↗ |
| K072568 | MODIFICATION TO OASYS SYSTEM | Stryker Spine | 2007-10-05 | Special | PDF ↗ |
| K070742 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2007-09-14 | Traditional | PDF ↗ |
| K071633 | LANX DEFORMITY SYSTEM | Lanx, LLC | 2007-08-15 | Special | PDF ↗ |
| K070341 | LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM | Ldr Spine USA | 2007-08-08 | Traditional | PDF ↗ |
| K071377 | POLARIS BE RODS | Biomet Spine | 2007-08-06 | Traditional | PDF ↗ |
| K070966 | GSO GS1 SPINAL SYSTEM | Gold Standard Orthopaedics, LLC | 2007-07-20 | Traditional | PDF ↗ |
| K070638 | THEKEN ATOLL CERVICO-THORACIC SYSTEM | Theken Spine, LLC | 2007-05-30 | Traditional | PDF ↗ |
| K061943 | ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM | Anatomica AB | 2007-05-25 | Traditional | PDF ↗ |
| K070300 | EXPEDIUM SFX CROSS CONNECTOR SYSTEM | Depuy Spine, Inc. | 2007-04-10 | Special | PDF ↗ |
| K062181 | C-JAWS CERVICAL COMPRESSIVE MINI FRAME | Medicrea Technologies | 2007-01-16 | Traditional | PDF ↗ |
| K062785 | LTD POLYAXIAL FIXATION SYSTEM | Us Spine | 2006-12-26 | Special | PDF ↗ |
| K062513 | APEX SPINE SYSTEM | Spinecraft, Inc. | 2006-12-22 | Traditional | PDF ↗ |
| K061591 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2006-09-08 | Special | PDF ↗ |
| K053418 | SYNTHES OC FUSION SYSTEM | Synthes Spine Co.Lp | 2006-09-06 | Traditional | PDF ↗ |
| K061579 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2006-08-11 | Special | PDF ↗ |
| K052404 | DENALI DEFORMITY SYSTEM | K2m, LLC | 2006-05-23 | Traditional | PDF ↗ |
| K060683 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | Endius, Inc. | 2006-04-18 | Traditional | PDF ↗ |
| K060513 | SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X | Sintea Biotech, Inc. | 2006-03-10 | Special | PDF ↗ |
| K060081 | BASIS SPINAL SYSTEM | Medtronic Sofamor Danek | 2006-02-13 | Traditional | PDF ↗ |
| K052201 | SOLANAS POSTERIOR STABILIZATION SYSTEM | Alphatec Spine, Inc. | 2005-11-10 | Traditional | PDF ↗ |
| K052734 | MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2005-10-21 | Special | PDF ↗ |
| K052131 | EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS | Depuy Spine, Inc. | 2005-09-28 | Special | PDF ↗ |
| K052402 | VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2005-09-23 | Traditional | PDF ↗ |
| K052123 | SYNTHES PANGEA SYSTEM | Synthes (Usa) | 2005-09-23 | Special | PDF ↗ |
| K052376 | MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2005-09-23 | Special | PDF ↗ |
| K052247 | NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX | Abbott Spine, Inc. | 2005-09-14 | Special | PDF ↗ |
| K052181 | MODIFICATION TO XIA SPINAL SYSTEM | Stryker Spine | 2005-09-08 | Special | PDF ↗ |
| K051716 | VERTEBRON PSS PEDICLE SCREW SYSTEM | Vertebron, Inc. | 2005-09-07 | Special | PDF ↗ |
| K052180 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2005-08-23 | Special | PDF ↗ |
| K051973 | MODIFICATION TO: XIA STAINLESS STEEL SYSTEM | Stryker Spine | 2005-08-18 | Special | PDF ↗ |
| K052069 | PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES | Globus Medical, Inc. | 2005-08-17 | Special | PDF ↗ |
| K051942 | MALIBU SPINAL SYSTEM | Seaspine, Inc. | 2005-07-27 | Traditional | PDF ↗ |
| K050391 | PROTEX CT CERVICOTHORACIC SPINAL SYSTEM | Globus Medical, Inc. | 2005-07-21 | Traditional | PDF ↗ |
| K050830 | ZODIAC SPINAL FIXATION SYSTEM | Alphatec/Nexmed | 2005-06-22 | Traditional | PDF ↗ |
| K050809 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2005-06-14 | Traditional | PDF ↗ |
| K050484 | BASIS SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2005-05-04 | Traditional | PDF ↗ |
| K043053 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2005-04-11 | Special | PDF ↗ |
| K050189 | TECHTONIX SYSTEM | Stryker Spine | 2005-02-16 | Special | PDF ↗ |
| K050079 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2005-02-10 | Special | PDF ↗ |
| K043522 | ISSYS PEDICLE SCREW SYSTEM | Custom Spine, Inc. | 2005-01-14 | Traditional | PDF ↗ |
| K043473 | MODIFICATION TO XIA SPINAL SYSTEM | Stryker Spine | 2005-01-12 | Special | PDF ↗ |
| K042635 | DENALI SPINE SYSTEM | K2m, LLC | 2005-01-10 | Traditional | PDF ↗ |
| K043020 | GLAXY 3.2 SPINAL SYSTEM | Medtronic Sofamor Danek | 2005-01-07 | Traditional | PDF ↗ |
| K043229 | MODIFICATION TO ALTIUS OCT SYSTEM | Interpore Cross Intl. | 2004-12-21 | Special | PDF ↗ |
| K042789 | VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2004-12-21 | Special | PDF ↗ |
| K043355 | SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X | Sintea Biotech, Inc. | 2004-12-17 | Special | PDF ↗ |
| K042673 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | Alphatec/Nexmed | 2004-10-27 | Special | PDF ↗ |
| K042524 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2004-10-08 | Special | PDF ↗ |
| K042508 | SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM | Depuy Spine, Inc. | 2004-10-07 | Special | PDF ↗ |
| K042498 | VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2004-10-07 | Special | PDF ↗ |
| K042143 | EXCELLA-M SPINAL SYSTEM | Innovasis, Inc. | 2004-10-07 | Traditional | PDF ↗ |
| K041808 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | Endius, Inc. | 2004-10-01 | Special | PDF ↗ |
| K042402 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-10-01 | Special | PDF ↗ |
| K041925 | ST360 SPINAL FIXATION SYSTEM | Zimmer Spine, Inc. | 2004-09-24 | Special | PDF ↗ |
| K041592 | CORAL SPINAL SYSTEM | Theken Surgical | 2004-09-16 | Traditional | PDF ↗ |
| K041862 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-09-15 | Special | PDF ↗ |
| K041119 | EXPEDIUM SPINE SYSTEM | Depuy Spine, Inc. | 2004-07-19 | Special | PDF ↗ |
| K041449 | SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT | Interpore Cross Intl. | 2004-07-01 | Special | PDF ↗ |
| K040096 | SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM | Spinal Concepts, Inc. | 2004-07-01 | Traditional | PDF ↗ |
| K041282 | MODIFICATION TO TSRH SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-06-10 | Special | PDF ↗ |
| K033961 | ALTIUS OCT SYSTEM | Interpore Cross Intl. | 2004-04-14 | Special | PDF ↗ |
| K033090 | ICON POLYAXIAL PEDICLE SCREW SYSTEM | Alphatec Mfg., Inc. | 2004-03-26 | Traditional | PDF ↗ |
| K033980 | BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) | Blackstone Medical, Inc. | 2004-03-03 | Special | PDF ↗ |
| K032094 | PASSMED SPINAL SYSTEM | Medicrea | 2003-11-14 | Traditional | PDF ↗ |
| K031175 | CLICK'X MONOAXIAL SCREWS AND HOOKS | Synthes (Usa) | 2003-11-14 | Traditional | PDF ↗ |
| K031471 | ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 | Ortho Tec, LLC | 2003-10-10 | Traditional | PDF ↗ |
| K031772 | TI FENESTRATED PLATE | Interpore Cross Intl. | 2003-09-05 | Abbreviated | PDF ↗ |
| K023884 | MODIFICATION ORIA SPINAL SYSTEM | Ortho Tec, LLC | 2003-08-20 | Traditional | PDF ↗ |
| K031893 | XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM | Howmedica Osteonics Corp. | 2003-07-17 | Special | PDF ↗ |
| K031595 | U & I AMERICA SPINAL HOOK SYSTEM | U&I Corp., America | 2003-06-24 | Traditional | PDF ↗ |
| K030875 | MODIFICATION TO COLORADO 2 SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2003-06-24 | Special | PDF ↗ |
| K031452 | ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 | Ortho Tec, LLC | 2003-06-18 | Special | PDF ↗ |
| K031533 | VANTAGE ANTERIOR FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2003-06-13 | Special | PDF ↗ |
| K030197 | BLACKSTONE POSTERIOR CERVICAL SYSTEM | Blackstone Medical, Inc. | 2003-06-12 | Traditional | PDF ↗ |
| K030816 | MSD CABLE REDUCTION SYSTEM | Medtronic Sofamor Danek | 2003-06-06 | Traditional | PDF ↗ |
| K031090 | MODIFICATION TO XIA STAINLESS STEEL SYSTEM | Howmedica Osteonics Corp. | 2003-04-24 | Special | PDF ↗ |
| K030241 | MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM | Blackstone Medical, Inc. | 2003-02-21 | Special | PDF ↗ |
| K030252 | ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) | Ortho Tec, LLC | 2003-02-21 | Special | PDF ↗ |
| K030253 | ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 | Ortho Tec, LLC | 2003-02-21 | Special | PDF ↗ |
| K023804 | MOSS MIAMI SPINAL SYSTEM PIN NUT | Depuyacromed | 2003-01-23 | Special | PDF ↗ |
| K023797 | LAURAIN DEWALD ANTERIOR FIXATION SYSTEM | Medtronic Sofamor Danek | 2002-12-13 | Special | PDF ↗ |
| K023415 | MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM | Medtronic Sofamor Danek | 2002-12-13 | Special | PDF ↗ |
| K014296 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2002-12-10 | Traditional | PDF ↗ |
| K022048 | INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM | Interpore Cross Intl. | 2002-12-04 | Traditional | PDF ↗ |
| K023675 | SYNTHES CERVIFIX/ AXON | Synthes (Usa) | 2002-11-26 | Special | PDF ↗ |
| K023555 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-11-22 | Special | PDF ↗ |
| K021679 | ORIA SPINAL CLIP SYSTEM | Ortho Tec, LLC | 2002-11-19 | Traditional | PDF ↗ |
| K023498 | MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM | Blackstone Medical, Inc. | 2002-11-13 | Special | PDF ↗ |
| K022374 | CADENCE SPINAL FIXATION SYSTEM | Sulzer Spine-Tech | 2002-09-24 | Special | PDF ↗ |
| K022191 | MODIFICATION TO TENOR SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2002-08-28 | Special | PDF ↗ |
| K022623 | 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) | Depuyacromed | 2002-08-27 | Special | PDF ↗ |
| K021507 | PLUS PIVOT LINK UNIVERSAL SYSTEM | Spine Vision, Inc. | 2002-08-01 | Traditional | PDF ↗ |
| K021061 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2002-07-25 | Special | PDF ↗ |
Product code KWP · Class II · Orthopedic. Data: openFDA.