K983508 is an FDA 510(k) clearance for the OSTEO COMPRESSION CONDYLE SCREW SYSTEM. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Osteonics Corp. (Allendale,, US). The FDA issued a Cleared decision on December 7, 1998, 61 days after receiving the submission on October 7, 1998.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K983508 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1998 |
| Decision Date | December 07, 1998 |
| Days to Decision | 61 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 |