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FDA 510(k)

COPAL® exchange G hip spacer; COPAL® G+V

K-Number: K234028 · 2024-02-15

ApplicantHeraeus Medical GmbH
Decision Date2024-02-15
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COPAL® exchange G hip spacer; COPAL® G+V is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical GmbH. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K234028. 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 COPAL® exchange G hip spacer; COPAL® G+V?

COPAL® exchange G hip spacer; COPAL® G+V is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K234028.

When did COPAL® exchange G hip spacer; COPAL® G+V receive FDA 510(k) clearance?

COPAL® exchange G hip spacer; COPAL® G+V received FDA 510(k) clearance on 2024-02-15, under 510(k) number K234028.

Who is the listed applicant for COPAL® exchange G hip spacer; COPAL® G+V?

The FDA 510(k) record lists Heraeus Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COPAL® exchange G hip spacer; COPAL® G+V?

The FDA product code for COPAL® exchange G hip spacer; COPAL® G+V is KWL.

Other records listing Heraeus Medical GmbH 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.

K241674OSTEOPAL® VK222570COPAL knee mouldsK220492COPAL exchange G hip spacerK213812PALACOS MV proK210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proK202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G

View all 11 devices →

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, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K222632UHR 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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