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FDA 510(k)

CoreHip® System

K-Number: K172235 · 2018-03-28

ApplicantAesculap Implants Systems, LLC
Decision Date2018-03-28
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoreHip® System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implants Systems, LLC. It received FDA 510(k) clearance on 2018-03-28 under 510(k) number K172235. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoreHip® System?

CoreHip® System is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is Aesculap Implants Systems, LLC. The 510(k) number is K172235.

When did CoreHip® System receive FDA 510(k) clearance?

CoreHip® System received FDA 510(k) clearance on 2018-03-28, under 510(k) number K172235.

Who is the listed applicant for CoreHip® System?

The FDA 510(k) record lists Aesculap Implants Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoreHip® System?

The FDA product code for CoreHip® System is LZO.

Other records listing Aesculap Implants Systems, LLC 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.

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Related Devices (Code: LZO)

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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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.

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