Cleared Special

InterSpace GV Hip Spacer

K252326 · Tecres S.P.A. · Orthopedic
Aug 2025
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K252326 is an FDA 510(k) clearance for the InterSpace GV Hip Spacer, 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 review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K252326 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360

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