K220142 is an FDA 510(k) clearance for the BRM Digitalis Spacer. This device is classified as a Prosthesis, Finger, Constrained, Polymer (Class II - Special Controls, product code KYJ).
Submitted by Brm Extremities Srl (Civate, IT). The FDA issued a Cleared decision on April 4, 2023, 441 days after receiving the submission on January 18, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3230.
| 510(k) Number | K220142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2022 |
| Decision Date | April 04, 2023 |
| Days to Decision | 441 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KYJ - Prosthesis, Finger, Constrained, Polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3230 |