K181184 is an FDA 510(k) clearance for the OIC Intramedullary Nail System. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by The Orthopaedic Implant Company (Reno, US). The FDA issued a Cleared decision on July 27, 2018, 85 days after receiving the submission on May 3, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K181184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2018 |
| Decision Date | July 27, 2018 |
| Days to Decision | 85 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB - Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |