K020266 is an FDA 510(k) clearance for the INION CPS BSSO 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 February 22, 2002, 28 days after receiving the submission on January 25, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K020266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2002 |
| Decision Date | February 22, 2002 |
| Days to Decision | 28 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 |