K855031 is an FDA 510(k) clearance for the MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Advanced Biosearch Assn. (Rockville, US). The FDA issued a Cleared decision on January 21, 1986, 36 days after receiving the submission on December 16, 1985.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K855031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1985 |
| Decision Date | January 21, 1986 |
| Days to Decision | 36 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 |