K080997 is an FDA 510(k) clearance for the ASCENSION PYROCARBON LUNATE. This device is classified as a Prosthesis, Wrist, Carpal Lunate (Class II - Special Controls, product code KWN).
Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on June 17, 2008, 70 days after receiving the submission on April 8, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3750.
| 510(k) Number | K080997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2008 |
| Decision Date | June 17, 2008 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWN — Prosthesis, Wrist, Carpal Lunate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3750 |