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 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K090779 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | Alphatec Spine, Inc. | 2009-07-07 | Special | PDF ↗ |
| K090984 | INERTIA PEDICLE SCREW SYSTEM | Nexxt Spine, LLC | 2009-06-30 | Traditional | PDF ↗ |
| K090033 | MODIFICATION TO: PSS SYSTEM | Spinal USA | 2009-05-06 | Special | PDF ↗ |
| K083863 | THEKEN ATOLL OCT SPINAL SYSTEM | Theken Spine, LLC | 2009-03-27 | Traditional | PDF ↗ |
| K081978 | RELIANCE SPINAL SCREW SYSTEM | Reliance Medical Systems, LLC | 2009-03-26 | Traditional | PDF ↗ |
| K083073 | THEKEN ATOLL CERVICO-THORACIC SYSTEM | Theken Spine, LLC | 2009-03-13 | Special | PDF ↗ |
| K083178 | SOLAS ANATOMIX SPINAL SYSTEM | Biotechni America Spine Group, Inc. | 2009-02-23 | Traditional | PDF ↗ |
| K083865 | PILOT SPINAL SYSTEM | Life Spine | 2009-01-28 | Special | PDF ↗ |
| K082617 | TRAUSON GENERAL SPINAL SYSTEM (GSS) | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2009-01-15 | Traditional | PDF ↗ |
| K083743 | CAPSURE PS SYSTEM | Spine Wave, Inc. | 2009-01-13 | Special | PDF ↗ |
| K083353 | CAPSURE(R) PS SYSTEM | Spine Wave, Inc. | 2008-12-11 | Special | PDF ↗ |
| K083308 | PASS LP SPINAL SYSTEM | Medicrea Technologies | 2008-12-10 | Special | PDF ↗ |
| K081145 | MODIFICATION TO 4CIS VANE SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2008-11-05 | Special | PDF ↗ |
| K082069 | PASS 2 SPINAL SYSTEM | Medicrea Technologies | 2008-10-03 | Special | PDF ↗ |
| K081790 | MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM | Trinity Orthopedics, LLC | 2008-07-24 | Special | PDF ↗ |
| K080841 | COSMIC SYSTEM | Ulrich GmbH & Co. KG | 2008-07-23 | Traditional | PDF ↗ |
| K081158 | ZODIC POLYAXIAL SPINAL FIXATION SYSTEM | Alphatec Spine, Inc. | 2008-07-03 | Special | PDF ↗ |
| K081597 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM | Vertebron, Inc. | 2008-07-02 | Special | PDF ↗ |
| K071074 | MYKRES SPINAL SYSTEM | Showa Ika Kohgyo Co., Ltd. | 2008-07-02 | Traditional | PDF ↗ |
| K071668 | ORTHOBIOM SPINAL SYSTEM | Paradigm Spine | 2008-07-02 | Traditional | PDF ↗ |
| K080767 | CONQUEST SPINAL SYSTEM | Life Spine | 2008-05-21 | Special | PDF ↗ |
| K081228 | CAPSURE PS (R) SPINE SYSTEM | Spine Wave, Inc. | 2008-05-12 | Special | PDF ↗ |
| K080099 | PASS SPINAL SYSTEM | Medicrea Technologies | 2008-04-09 | Special | PDF ↗ |
| K080502 | MODIFICATION TO:PILOT SPINAL SYSTEM | Life Spine | 2008-04-08 | Special | PDF ↗ |
| K080792 | K2M COCR ROD | K2m, Inc. | 2008-04-08 | Special | PDF ↗ |
| K073143 | MODIFIED VERTIFLEX SPINAL SCREW SYSTEM | Vertiflex, Inc. | 2008-04-07 | Traditional | PDF ↗ |
| K073240 | PSS SYSTEM | Spinal USA | 2008-03-20 | Special | PDF ↗ |
| K080407 | BLACKSTONE SFS PARALLEL ROD CONNECTORS | Blackstone Medical, Inc. | 2008-03-13 | Special | PDF ↗ |
| K080143 | MODIFICATION TO STRYKER SPINE OASYS SYSTEM | Stryker Spine | 2008-02-14 | Special | PDF ↗ |
| K080026 | QUANTUM-MIS CANNULATED SYSTEM | Pioneer Surgical Technology | 2008-01-28 | Special | PDF ↗ |
| K080075 | MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM | Elite Surgical Supplies (Pty), Ltd. | 2008-01-28 | Special | PDF ↗ |
| K072434 | SYNTHES OC FUSION AND SYNAPSE SYSTEMS | Synthes Spine Co.Lp | 2008-01-10 | Traditional | PDF ↗ |
| K072914 | NATURAL BRIDGE LP TRANSVERSE CONNECTORS | K2m, Inc. | 2008-01-03 | Traditional | PDF ↗ |
| K072436 | MEGA SPINE SYSTEM | Bk Meditech, Co., Ltd. | 2007-11-01 | Traditional | PDF ↗ |
| K072187 | PIONEER LOWTOP SPINAL ROD SYSTEM | Pioneer Surgical Technology | 2007-10-12 | Traditional | PDF ↗ |
| K071880 | Optima ZS Transition Screw | Zimmer Spine, Inc. | 2007-10-05 | Traditional | PDF ↗ |
| K070276 | MODIFICATION TO PASSMED SPINAL SYSTEM | Medicrea Technologies | 2007-09-21 | Special | PDF ↗ |
| K071877 | LANX SPINAL FIXATION SYSTEM | Lanx, LLC | 2007-09-17 | Traditional | PDF ↗ |
| K071824 | ACME TALON PEDICLE SCREW | Acme Spine, LLC | 2007-09-04 | Special | PDF ↗ |
| K063453 | VERTEFIX PEDICLE SCREW SPINAL SYSTEM | Elite Surgical Supplies (Pty), Ltd. | 2007-08-30 | Traditional | PDF ↗ |
| K071438 | PSS SYSTEM | Spinal USA | 2007-08-21 | Traditional | PDF ↗ |
| K071857 | DELTA SPINAL FUSION SYSTEM | Jemo Spine, LLC | 2007-08-08 | Traditional | PDF ↗ |
| K071435 | NUVASIVE OCT SYSTEM | Nuvasive, Inc. | 2007-08-06 | Traditional | PDF ↗ |
| K071743 | PILLAR PEDICLE SCREW SYSTEM | The 4th Column, LLC | 2007-07-06 | Traditional | PDF ↗ |
| K070573 | SYNAPSE SYSTEM | Synthes Spine Co.Lp | 2007-06-08 | Special | PDF ↗ |
| K070295 | SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM | Trinity Orthopedics, LLC | 2007-05-21 | Traditional | PDF ↗ |
| K063668 | ROC LUMBAR SYSTEM | Alphatec Spine, Inc. | 2007-05-18 | Traditional | PDF ↗ |
| K070229 | RANGE SPINAL SYSTEM | K2m, Inc. | 2007-05-03 | Traditional | PDF ↗ |
| K063708 | 4S SPINAL SYSTEM | Taeyeon Medical Co., Ltd. | 2007-04-24 | Traditional | PDF ↗ |
| K070245 | CAPSURE PEDICLE SCREW SYSTEM | Spine Wave, Inc. | 2007-04-05 | Traditional | PDF ↗ |
| K062912 | SCIENT'X SPINAL SYSTEM | Scient'X | 2007-02-05 | Special | PDF ↗ |
| K063601 | PILOT SPINAL SYSTEM | Life Spine | 2007-01-25 | Traditional | PDF ↗ |
| K063794 | MODIFICATION TO EASYSPINE SYSTEM | Ldr Spine USA | 2007-01-24 | Special | PDF ↗ |
| K062879 | TRAVERSE OCT SPINAL FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2006-12-22 | Traditional | PDF ↗ |
| K062934 | SIERRA | Seaspine, Inc. | 2006-11-16 | Traditional | PDF ↗ |
| K062853 | MODIFICATION TO STRYKER SPINE OASYS SYSTEM | Stryker Spine | 2006-10-24 | Special | PDF ↗ |
| K062698 | TRIO + SPINAL SYSTEM | Stryker Spine | 2006-10-11 | Special | PDF ↗ |
| K062136 | PASS 2 SPINAL SYSTEM | Medicrea | 2006-10-06 | Traditional | PDF ↗ |
| K062505 | NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES | Abbott Spine, Inc. | 2006-09-26 | Special | PDF ↗ |
| K062606 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2006-09-25 | Special | PDF ↗ |
| K061600 | ARX SPINAL SYSTEM | Life Spine | 2006-08-22 | Traditional | PDF ↗ |
| K061978 | EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM | Ebi, L.P. | 2006-08-11 | Special | PDF ↗ |
| K061017 | EASYSPINE SYSTEM | Ldr Spine USA | 2006-08-10 | Special | PDF ↗ |
| K051704 | MYKRES SPINAL SYSTEM | Showa Ika Kohgyo Co., Ltd. | 2006-07-03 | Traditional | PDF ↗ |
| K060634 | NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES | Abbott Spine, Inc. | 2006-03-31 | Traditional | PDF ↗ |
| K060152 | MODIFICATION TO S4 SPINAL SYSTEM | Aesculap, Inc. | 2006-02-03 | Special | PDF ↗ |
| K052566 | NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY | Abbott Spine, Inc. | 2006-01-06 | Special | PDF ↗ |
| K053483 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2006-01-05 | Special | PDF ↗ |
| K052847 | CAPLESS PEDICLE SCREW SYSTEM | X-Spine Systems, Inc. | 2005-12-12 | Traditional | PDF ↗ |
| K052398 | MESA SPINAL SYSTEM | K2m, LLC | 2005-12-07 | Traditional | PDF ↗ |
| K053115 | XIA SPINAL SYSTEM | Stryker Spine | 2005-12-06 | Special | PDF ↗ |
| K052971 | STRYKER SPINE TRIO SPINAL FIXATION SYSTEM | Stryker Spine | 2005-11-16 | Special | PDF ↗ |
| K052406 | UNI-THREAD SPINAL SYSTEM | Spine Vision, Inc. | 2005-11-07 | Traditional | PDF ↗ |
| K052761 | MODIFICATION TO: XIA 4.5 SPINAL SYSTEM | Stryker Spine | 2005-10-11 | Special | PDF ↗ |
| K052317 | MODIFICATION TO: STRYKER SPINE OASYS SYSTEM | Stryker Spine | 2005-09-21 | Special | PDF ↗ |
| K050979 | S4 SPINAL SYSTEM | Aesculap, Inc. | 2005-07-27 | Traditional | PDF ↗ |
| K051063 | POLYAXIAL HEMISPHERICAL SPINAL SCREWS | Scient'X | 2005-05-23 | Special | PDF ↗ |
| K050981 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2005-05-17 | Special | PDF ↗ |
| K043484 | LANX SPINAL FIXATION SYSTEM | Lanx, LLC | 2005-05-16 | Abbreviated | PDF ↗ |
| K050060 | LAGUNA PEDICLE SCREW SYSTEM | Allez Spine, LLC | 2005-05-04 | Traditional | PDF ↗ |
| K050675 | EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE | Depuy Spine, Inc. | 2005-04-11 | Traditional | PDF ↗ |
| K043094 | EASYSPINE SYSTEM | Ldr Spine USA | 2005-02-11 | Traditional | PDF ↗ |
| K042210 | MSD SILO SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-11-04 | Traditional | PDF ↗ |
| K042453 | MODIFICATION TO EQUATION FIXATION SYSTEM | Medtronic Sofamor Danek, Inc. | 2004-10-07 | Special | PDF ↗ |
| K042514 | MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM | Blackstone Medical, Inc. | 2004-10-07 | Special | PDF ↗ |
| K042100 | BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR | Blackstone Medical, Inc. | 2004-09-20 | Traditional | PDF ↗ |
| K041777 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-09-03 | Special | PDF ↗ |
| K040493 | OUTOLOGOUS SPINAL FIXATION SYSTEM | Orthopedic Sciences, Inc. | 2004-09-03 | Traditional | PDF ↗ |
| K033826 | ORTHOPEDIC ALLIANCE SPINE SYSTEM | Orthopedic Alliance, LLC | 2004-07-01 | Traditional | PDF ↗ |
| K041030 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-06-30 | Special | PDF ↗ |
| K041203 | SUMMIT OCT SPINAL SYSTEM | Depuy Spine, Inc. | 2004-06-02 | Special | PDF ↗ |
| K041118 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-05-28 | Special | PDF ↗ |
| K040583 | MODIFICATION TO: CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-03-31 | Special | PDF ↗ |
| K040346 | MODIFICATION TO ORIA TOP CLIP SYSTEM | Ortho Tec, LLC | 2004-03-12 | Special | PDF ↗ |
| K033947 | SHIRAZ POSTERIOR SYSTEM | Spine Next America | 2004-03-04 | Traditional | PDF ↗ |
| K033150 | ART POSTERIOR SPINAL SYSTEM | Advanced Medical Technologies AG | 2004-03-01 | Traditional | PDF ↗ |
| K033352 | VERTEBRON PSS PEDICLE SCREW SYSTEM | Vertebron, Inc. | 2004-02-25 | Traditional | PDF ↗ |
| K032394 | STRYKER SPINE OASYS SYSTEM | Howmedica Osteonics Corp. | 2004-02-20 | Traditional | PDF ↗ |
| K040034 | BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER | Blackstone Medical, Inc. | 2004-02-11 | Special | PDF ↗ |
| K033772 | SHIRAZ-JAVA SPINAL FIXATION SYSTEM | Spine Next America | 2004-01-27 | Traditional | PDF ↗ |
Product code MNI · Class II · Orthopedic. Data: openFDA.