K854887 is an FDA 510(k) clearance for the MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT. This device is classified as a Forceps, Rongeur, Surgical (Class I - General Controls, product code EMH).
Submitted by Walter Lorenz Surgical, Inc. (Rockville, US). The FDA issued a Cleared decision on February 28, 1986, 84 days after receiving the submission on December 6, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K854887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1985 |
| Decision Date | February 28, 1986 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EMH — Forceps, Rongeur, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |