K002103 is an FDA 510(k) clearance for the SIMPLICITY SPINAL SYSTEM. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on November 2, 2000, 113 days after receiving the submission on July 12, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K002103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2000 |
| Decision Date | November 02, 2000 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| 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 |