K080358 is an FDA 510(k) clearance for the PLLA, HA SCREW. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Smith & Nephew Inc., Endoscopy Div. (Andover, US). The FDA issued a Cleared decision on April 23, 2008, 72 days after receiving the submission on February 11, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K080358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2008 |
| Decision Date | April 23, 2008 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |