K913415 is an FDA 510(k) clearance for the AESCULAP TITANIUM 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 October 29, 1991, 90 days after receiving the submission on July 31, 1991.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K913415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | July 31, 1991 |
| Decision Date | October 29, 1991 |
| Days to Decision | 90 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 |