K081228 is an FDA 510(k) clearance for the CAPSURE PS (R) SPINE SYSTEM. This device is classified as a Orthosis, Spinal Pedicle Fixation (Class II - Special Controls, product code MNI).
Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on May 12, 2008, 12 days after receiving the submission on April 30, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K081228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2008 |
| Decision Date | May 12, 2008 |
| Days to Decision | 12 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNI — Orthosis, Spinal Pedicle Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |