Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Heraeus Medical GmbH. It received FDA 510(k) clearance on 2024-02-15 under approval 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. It is manufactured by Heraeus Medical GmbH. The 510(k) number is K234028.

When was COPAL® exchange G hip spacer; COPAL® G+V approved by the FDA?

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

What company makes COPAL® exchange G hip spacer; COPAL® G+V?

COPAL® exchange G hip spacer; COPAL® G+V is manufactured by Heraeus Medical GmbH.

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 Devices by Heraeus Medical GmbH

K153737OSTEOPAL plus K182260PALACOS MV K191016COPAL exchange G Hip and Knee Spacers K190766PALACOS fast R+G K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro

View all 11 devices →

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 K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC

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.

↑