510(k) K252326

InterSpace GV Hip Spacer by Tecres S.P.A. — Product Code KWL

K252326 is an FDA 510(k) premarket notification submitted by Tecres S.P.A. for the device "InterSpace GV Hip Spacer". The FDA issued a decision of Substantially Equivalent on August 6, 2025. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Tecres S.P.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2025
Date Received
July 25, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type