K053338 is an FDA 510(k) clearance for the ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on January 26, 2006, 56 days after receiving the submission on December 1, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K053338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2005 |
| Decision Date | January 26, 2006 |
| Days to Decision | 56 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 |