K931538 is an FDA 510(k) clearance for the AMSET(TM) CANNULATED BONE SCREW. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Advanced Med/Surg, Inc. (Hayward, US). The FDA issued a Cleared decision on May 4, 1994, 401 days after receiving the submission on March 29, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K931538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | March 29, 1993 |
| Decision Date | May 04, 1994 |
| Days to Decision | 401 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 |