K052069 is an FDA 510(k) clearance for the PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Globus Medical, Inc. (Phoenixville, US). The FDA issued a Cleared decision on August 17, 2005, 16 days after receiving the submission on August 1, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K052069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2005 |
| Decision Date | August 17, 2005 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWP — Appliance, Fixation, Spinal Interlaminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3050 |