K953198 is an FDA 510(k) clearance for the CORTICELLOUS BONE SCREW. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Hayes Medical, Inc. (Sacramento, US). The FDA issued a Cleared decision on November 24, 1995, 141 days after receiving the submission on July 6, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K953198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | July 06, 1995 |
| Decision Date | November 24, 1995 |
| Days to Decision | 141 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 |