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FDA 510(k)

ICONACY(TM) I-Hip (TM)

K-Number: K151307 · 2016-02-26

ApplicantIconacy Orthopedic Implants, LLC
Decision Date2016-02-26
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ICONACY(TM) I-Hip (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Iconacy Orthopedic Implants, LLC. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K151307. 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 ICONACY(TM) I-Hip (TM)?

ICONACY(TM) I-Hip (TM) is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is Iconacy Orthopedic Implants, LLC. The 510(k) number is K151307.

When did ICONACY(TM) I-Hip (TM) receive FDA 510(k) clearance?

ICONACY(TM) I-Hip (TM) received FDA 510(k) clearance on 2016-02-26, under 510(k) number K151307.

Who is the listed applicant for ICONACY(TM) I-Hip (TM)?

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

What is the FDA product code for ICONACY(TM) I-Hip (TM)?

The FDA product code for ICONACY(TM) I-Hip (TM) is LZO.

Other records listing Iconacy Orthopedic Implants, 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.

K160266ICONACY(TM) I-Hip(TM)

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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