K831873 is an FDA 510(k) clearance for the BONE SCREW. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by W.L. Gore & Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983, 60 days after receiving the submission on June 13, 1983.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K831873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 1983 |
| Decision Date | August 12, 1983 |
| Days to Decision | 60 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 |