FDA 510(k)

InterSpace GV Hip Spacer

K-Number: K252326 · 2025-08-06

Decision Date2025-08-06

Product CodeKWL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

InterSpace GV Hip Spacer is a medical device manufactured by Tecres S.P.A.. It received FDA 510(k) clearance on 2025-08-06 under approval number K252326. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InterSpace GV Hip Spacer?

InterSpace GV Hip Spacer is a medical device that received FDA 510(k) clearance on 2025-08-06. It is manufactured by Tecres S.P.A.. The 510(k) number is K252326.

When was InterSpace GV Hip Spacer approved by the FDA?

InterSpace GV Hip Spacer received FDA 510(k) clearance on 2025-08-06, under approval number K252326.

What company makes InterSpace GV Hip Spacer?

InterSpace GV Hip Spacer is manufactured by Tecres S.P.A..

What is the FDA product code for InterSpace GV Hip Spacer?

The FDA product code for InterSpace GV Hip Spacer is KWL.

Other Devices by Tecres S.P.A.

K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATS K220131KYPHON VuE Bone Cement K211163Bone Cement Genta, Bone Cement HV, Bone Cement LV

Related Devices (Code: KWL)

K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC K173967Remedy Acetabular CupOsteoremedies, LLC K191981REMEDY Acetabular CupOsteoremedies, LLC K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.