FDA 510(k)

ICONACY(TM) I-Hip(TM)

K-Number: K160266 · 2016-04-08

ApplicantIconacy Orthopedic Implants, LLC

Decision Date2016-04-08

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ICONACY(TM) I-Hip(TM) is a medical device manufactured by Iconacy Orthopedic Implants, LLC. It received FDA 510(k) clearance on 2016-04-08 under approval number K160266. The device is classified under product code LPH. 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 2016-04-08. It is manufactured by Iconacy Orthopedic Implants, LLC. The 510(k) number is K160266.

When was ICONACY(TM) I-Hip(TM) approved by the FDA?

ICONACY(TM) I-Hip(TM) received FDA 510(k) clearance on 2016-04-08, under approval number K160266.

What company makes ICONACY(TM) I-Hip(TM)?

ICONACY(TM) I-Hip(TM) is manufactured by Iconacy Orthopedic Implants, LLC.

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

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

Other Devices by Iconacy Orthopedic Implants, LLC

K151307ICONACY(TM) I-Hip (TM)

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, 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.