K031127 is an FDA 510(k) clearance for the ORTHOPEDIC WIRE. This device is classified as a Staple, Fixation, Bone (Class II - Special Controls, product code JDR).
Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 28, 2003, 19 days after receiving the submission on April 9, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K031127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2003 |
| Decision Date | April 28, 2003 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDR — Staple, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |