K191641 is an FDA 510(k) clearance for the AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Industrias Medicas Sampedro S.A.S (La Estrella, CO). The FDA issued a Cleared decision on September 16, 2019, 89 days after receiving the submission on June 19, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K191641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2019 |
| Decision Date | September 16, 2019 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS - Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |