K974186 is an FDA 510(k) clearance for the ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Orthofix Srl (Rockville, US). The FDA issued a Cleared decision on March 18, 1998, 131 days after receiving the submission on November 7, 1997.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K974186 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1997 |
| Decision Date | March 18, 1998 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDW — Pin, Fixation, Threaded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |