Product code KWP
- Device name
- Appliance, Fixation, Spinal Interlaminal
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3050
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2015-07-29 |
| K150753 | OASYS System | Stryker Corporation | 2015-06-09 |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | Precision Spine, Inc. | 2015-06-04 |
| K142867 | Reliance Posterior Cervical-Thoracic System | Reliance Medical Systems, LLC | 2015-04-29 |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-04-28 |
| K142253 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-23 |
| K150229 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-07 |
| K143249 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-07 |
| K142741 | OASYS System | Stryker Corporation | 2015-01-15 |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m | 2014-12-22 |
| K140734 | NEXTGEN ALTIUS OCT SYSTEM | Ebi, LLC | 2014-12-15 |
| K142460 | EXPEDIUM Spine System/Synapse System | Johnson and Johnson | 2014-10-01 |
| K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | Synthes USA Products, LLC | 2014-09-25 |
| K141284 | CASPIAN SPINAL SYSTEM | K2m, Inc. | 2014-07-23 |
| K133288 | CASPIAN OCT SPINAL SYSTEM | K2m, Inc. | 2014-07-01 |
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | Zimmer Spine, Inc. | 2014-06-02 |
| K140645 | GIBRALT ROD-TO-ROD CROSS CONNECTORS | Exactech Sarasota | 2014-04-11 |
| K133374 | STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014-03-19 |
| K133214 | BLACKBIRD SPINAL SYSTEM | Choicespine, LP | 2014-03-07 |
| K131833 | CENTURION POCT SYSTEM | Orthofix, Inc. | 2014-01-30 |
| K132122 | KESTREL POSTERIOR CERVICAL SPINE SYSTEM | Omni Surgical, LLC Dba Spine360 | 2014-01-22 |
| K133698 | SYNAPSE SYSTEM | Synthes USA Products, LLC | 2014-01-16 |
| K133094 | CERTEX OCT SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2013-12-11 |
| K132504 | TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM | Corelink, LLC | 2013-11-25 |
| K132900 | MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM | Intelligent Implant Systems, LLC | 2013-10-25 |
| K131427 | LOTUS | Spinal Elements, Inc. | 2013-10-24 |
| K132332 | MOUNTAINEER OCT SPINAL SYSTEM | Medos International SARL | 2013-08-22 |
| K131156 | LANX SPINAL FIXATION SYSTEM | Lanx, Inc. | 2013-05-24 |
| K123906 | VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2013-04-01 |
| K121979 | PASS OCT SPINAL SYSTEM | Medicrea International | 2013-03-21 |
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| 00841732150805 | PREFERENCE Pedicle Screw System | CTL Medical Corporation | 2023-09-09 |
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