K051341 is an FDA 510(k) clearance for the INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on May 27, 2005, 4 days after receiving the submission on May 23, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K051341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2005 |
| Decision Date | May 27, 2005 |
| Days to Decision | 4 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |