InterSpace GV Hip Spacer— 510(k) K252326

Substantially Equivalent

Tecres S.P.A.

FDA 510(k) clearance K252326 for InterSpace GV Hip Spacer, Substantially Equivalent on 2025-08-06. Applicant: Tecres S.P.A..

Clearance details

Applicant: Tecres S.P.A.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 2025-07-25
Decision date: 2025-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Sommacampagna, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.