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FDA 510(k)

InterSpace GV Hip Spacer

K-Number: K252326 · 2025-08-06

ApplicantTecres S.P.A.
Decision Date2025-08-06
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

InterSpace GV Hip Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Tecres S.P.A.. It received FDA 510(k) clearance on 2025-08-06 under 510(k) 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. The listed applicant is Tecres S.P.A.. The 510(k) number is K252326.

When did InterSpace GV Hip Spacer receive FDA 510(k) clearance?

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

Who is the listed applicant for InterSpace GV Hip Spacer?

The FDA 510(k) record lists Tecres S.P.A. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Tecres S.P.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVK220131KYPHON VuE Bone CementK181732InterSpace Knee Extra-Large Size, InterSpace Knee ATS

Related Devices (Code: KWL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbHK222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Official Source

View on FDA Database →

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

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