KWP · Appliance, Fixation, Spinal Interlaminal
Orthopedic · 21 CFR 888.3050 · Class 2
Overview
| Product Code | KWP |
|---|---|
| Device Name | Appliance, Fixation, Spinal Interlaminal |
| Regulation | 21 CFR 888.3050 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 430)
Showing 20 most recent of 430 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | Jul 29, 2015 | SESE |
| K150753 | OASYS System | Stryker Corporation | Jun 9, 2015 | SESE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | Precision Spine, Inc. | Jun 4, 2015 | SESE |
| K142867 | Reliance Posterior Cervical-Thoracic System | Reliance Medical Systems, LLC | Apr 29, 2015 | SESE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Apr 28, 2015 | SESE |
| K142253 | SOLSTICE OCT System | Life Spine, Inc. | Apr 23, 2015 | SESE |
| K150229 | SOLSTICE OCT System | Life Spine, Inc. | Apr 7, 2015 | SESE |
| K143249 | SOLSTICE OCT System | Life Spine, Inc. | Apr 7, 2015 | SESE |
| K142741 | OASYS System | Stryker Corporation | Jan 15, 2015 | SESE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m | Dec 22, 2014 | SESE |
| K140734 | NEXTGEN ALTIUS OCT SYSTEM | Ebi, LLC | Dec 15, 2014 | SESE |
| K142460 | EXPEDIUM Spine System/Synapse System | Johnson and Johnson | Oct 1, 2014 | SESE |
| K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | Synthes USA Products, LLC | Sep 25, 2014 | SESE |
| K141284 | CASPIAN SPINAL SYSTEM | K2m, Inc. | Jul 23, 2014 | SESE |
| K133288 | CASPIAN OCT SPINAL SYSTEM | K2m, Inc. | Jul 1, 2014 | SESE |
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | Zimmer Spine, Inc. | Jun 2, 2014 | SESE |
| K140645 | GIBRALT ROD-TO-ROD CROSS CONNECTORS | Exactech Sarasota | Apr 11, 2014 | SESE |
| K133374 | STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM | Pioneer Surgical Technology, Inc. (Rti Surgical, I | Mar 19, 2014 | SESE |
| K133214 | BLACKBIRD SPINAL SYSTEM | Choicespine, LP | Mar 7, 2014 | SESE |
| K131833 | CENTURION POCT SYSTEM | Orthofix, Inc. | Jan 30, 2014 | SESE |
Top Applicants
- Medtronic Sofamor Danek — 25 clearances
- Medtronic Sofamor Danek, Inc. — 19 clearances
- Synthes (Usa) — 17 clearances
- Danek Medical, Inc. — 16 clearances
- Acromed Corp. — 14 clearances
