K895219 is an FDA 510(k) clearance for the CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on September 12, 1989, 25 days after receiving the submission on August 18, 1989.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K895219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1989 |
| Decision Date | September 12, 1989 |
| Days to Decision | 25 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 |