K965073 is an FDA 510(k) clearance for the 9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Smith & Nephew, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 27, 1997, 70 days after receiving the submission on December 19, 1996.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K965073 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1996 |
| Decision Date | February 27, 1997 |
| Days to Decision | 70 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 |