K022981 is an FDA 510(k) clearance for the INION CPS 2.5/2.8 SCREW. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on September 12, 2002, 3 days after receiving the submission on September 9, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K022981 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2002 |
| Decision Date | September 12, 2002 |
| Days to Decision | 3 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |