KWP — Appliance, Fixation, Spinal Interlaminal Class II
FDA product code KWP covers "Appliance, Fixation, Spinal Interlaminal", a Class II medical device regulated under 21 CFR 888.3050. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KWP
- Device Class
- Class II
- Regulation Number
- 888.3050
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143278 | l and k biomed co | LnK Posterior Cervical Fixation System | July 29, 2015 |
| K150753 | stryker corporation | OASYS System | June 9, 2015 |
| K150851 | precision spine | Sure Lok Mini Posterior Cervical/Upper Thoracic System | June 4, 2015 |
| K142867 | reliance medical systems | Reliance Posterior Cervical-Thoracic System | April 29, 2015 |
| K150254 | pioneer surgical technology, inc. (dba rti surgical, inc.) | Streamline OCT Occipito-Cervico-Thoracic System | April 28, 2015 |
| K142253 | life spine | SOLSTICE OCT System | April 23, 2015 |
| K150229 | life spine | SOLSTICE OCT System | April 7, 2015 |
| K143249 | life spine | SOLSTICE OCT System | April 7, 2015 |
| K142741 | stryker corporation | OASYS System | January 15, 2015 |
| K142558 | k2m | Caspian OCT/MESA Mini/DENALI Mini Spinal System | December 22, 2014 |
| K140734 | ebi | NEXTGEN ALTIUS OCT SYSTEM | December 15, 2014 |
| K142460 | johnson and johnson | EXPEDIUM Spine System/Synapse System | October 1, 2014 |
| K141897 | synthes usa products | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | September 25, 2014 |
| K141284 | k2m | CASPIAN SPINAL SYSTEM | July 23, 2014 |
| K133288 | k2m | CASPIAN OCT SPINAL SYSTEM | July 1, 2014 |
| K133556 | zimmer spine | VIRAGE OCT SPINAL FIXATION SYSTEM | June 2, 2014 |
| K140645 | exactech sarasota | GIBRALT ROD-TO-ROD CROSS CONNECTORS | April 11, 2014 |
| K133374 | pioneer surgical technology, inc. (rti surgical, i | STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM | March 19, 2014 |
| K133214 | choicespine | BLACKBIRD SPINAL SYSTEM | March 7, 2014 |
| K131833 | orthofix | CENTURION POCT SYSTEM | January 30, 2014 |