K990353 is an FDA 510(k) clearance for the STAINLESS STEEL FIXATION PINS. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Bregma International Trading Company , Ltd. (Saskatoon, Saskatchewan, CA). The FDA issued a Cleared decision on June 1, 1999, 116 days after receiving the submission on February 5, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K990353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1999 |
| Decision Date | June 01, 1999 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | JDW — Pin, Fixation, Threaded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |