K923705 is an FDA 510(k) clearance for the AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on February 1, 1994, 557 days after receiving the submission on July 24, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K923705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1992 |
| Decision Date | February 01, 1994 |
| Days to Decision | 557 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |