K974785 is an FDA 510(k) clearance for the AUTO-DRIVE BONE SCREW. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on March 18, 1998, 86 days after receiving the submission on December 22, 1997.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K974785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1997 |
| Decision Date | March 18, 1998 |
| Days to Decision | 86 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 |