K913730 is an FDA 510(k) clearance for the AESCULAP TITANIUM BONE PLATES. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on March 12, 1992, 205 days after receiving the submission on August 20, 1991.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K913730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1991 |
| Decision Date | March 12, 1992 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | KWQ — Appliance, Fixation, Spinal Intervertebral Body |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |