K252326 is an FDA 510(k) clearance for the InterSpace GV Hip Spacer. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Tecres S.P.A. (Sommacampagna, IT). The FDA issued a Cleared decision on August 6, 2025, 12 days after receiving the submission on July 25, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K252326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2025 |
| Decision Date | August 06, 2025 |
| Days to Decision | 12 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWL - Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |