K202348 is an FDA 510(k) clearance for the External Remote Controller ERC 4P. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Nuvasive Specialized Orthopedics, Inc. (Alisa Viejo, US). The FDA issued a Cleared decision on December 22, 2020, 126 days after receiving the submission on August 18, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K202348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2020 |
| Decision Date | December 22, 2020 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| 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 |