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

FDA 510(k)

COPAL exchange G hip spacer

K-Number: K220492 · 2022-03-23

ApplicantHeraeus Medical GmbH
Decision Date2022-03-23
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COPAL exchange G hip spacer 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 2022-03-23 under 510(k) number K220492. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPAL exchange G hip spacer?

COPAL exchange G hip spacer is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K220492.

When did COPAL exchange G hip spacer receive FDA 510(k) clearance?

COPAL exchange G hip spacer received FDA 510(k) clearance on 2022-03-23, under 510(k) number K220492.

Who is the listed applicant for COPAL exchange G hip spacer?

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?

The FDA product code for COPAL exchange G hip spacer is KWY.

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® VK234028COPAL® exchange G hip spacer; COPAL® G+VK222570COPAL knee mouldsK213812PALACOS 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: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.

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.

↑