K193543 is an FDA 510(k) clearance for the CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on January 17, 2020, 28 days after receiving the submission on December 20, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K193543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2019 |
| Decision Date | January 17, 2020 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |