InterSpace GV Hip Spacer
FDA 510(k) K252326 · Tecres S.P.A.
510(k) numberK252326
Submission
- Device name
- InterSpace GV Hip Spacer
- Applicant
- Tecres S.P.A.
Sommacampagna, IT - Received
- July 25, 2025
- Decision date
- August 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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| K122175 | Mendec Spine HV, Mendec Spine HV SystemNDN · Traditional | 03/28/2013SE |
| K112983 | Spacer-SHSD · Traditional | 12/12/2011SE |
| K101356 | Spacer-G and Spacer-KKWL · Traditional | 09/20/2011SE |
| K092773 | Cemex Genta, Genta System and Genta System FastLOD · Special | 11/24/2009SE |
| K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321JWH · Traditional | 05/22/2008SE |
| K062273 | Spacer-G Temporary Hip ProsthesisKWL · Traditional | 05/22/2008SE |
| K063438 | VspspnNDN · Traditional | 01/17/2007SE |
Questions and answers
When was InterSpace GV Hip Spacer cleared by the FDA?
InterSpace GV Hip Spacer (K252326) received a 510(k) decision of Substantially Equivalent on August 6, 2025, 12 days after the submission was received.
What is the product code of K252326?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.