K122637 is an FDA 510(k) clearance for the LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999. This device is classified as a Light, Surgical, Fiberoptic (Class II - Special Controls, product code FST).
Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on November 1, 2012, 64 days after receiving the submission on August 29, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K122637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2012 |
| Decision Date | November 01, 2012 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FST — Light, Surgical, Fiberoptic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |