K963118 is an FDA 510(k) clearance for the EXTREMITY BONE SCREW. This device is classified as a Screw, Fixation, Bone (Class II — Special Controls, product code HWC).
Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on October 10, 1996, 59 days after receiving the submission on August 12, 1996.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K963118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | August 12, 1996 |
| Decision Date | October 10, 1996 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3040 |