K223441 is an FDA 510(k) clearance for the SpaceFlex Acetabular Cup. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II - Special Controls, product code KWY).
Submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on March 23, 2023, 129 days after receiving the submission on November 14, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3390.
| 510(k) Number | K223441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2022 |
| Decision Date | March 23, 2023 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWY - Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3390 |