K881511 is an FDA 510(k) clearance for the FIXATOR PIN (EXTERNAL). This device is classified as a Pin, Fixation, Threaded (Class II — Special Controls, product code JDW).
Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on June 30, 1988, 80 days after receiving the submission on April 11, 1988.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K881511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1988 |
| Decision Date | June 30, 1988 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDW — Pin, Fixation, Threaded |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3040 |