K970549 is an FDA 510(k) clearance for the TITANIUM ALLOY BONE SCREWS. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on April 30, 1997, 77 days after receiving the submission on February 12, 1997.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K970549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | February 12, 1997 |
| Decision Date | April 30, 1997 |
| Days to Decision | 77 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 |