K201701 is an FDA 510(k) clearance for the R3 HA Coated Acetabular Shells. This device is classified as a Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous (Class II - Special Controls, product code MBL).
Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on October 6, 2020, 106 days after receiving the submission on June 22, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K201701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2020 |
| Decision Date | October 06, 2020 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBL — Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |