K190385 is an FDA 510(k) clearance for the CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple 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 August 8, 2019, 170 days after receiving the submission on February 19, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K190385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2019 |
| Decision Date | August 08, 2019 |
| Days to Decision | 170 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 |