K931155 is an FDA 510(k) clearance for the STAPLE, FIXATION BONE; SCREW FIXATION BONE. This device is classified as a Screw, Fixation, Bone (Class II — Special Controls, product code HWC).
Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on September 1, 1994, 541 days after receiving the submission on March 9, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K931155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1993 |
| Decision Date | September 01, 1994 |
| Days to Decision | 541 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3040 |