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FDA 510(k)

ICONACY I-HIP SYSTEM

K-Number: K131279 · 2013-08-09

ApplicantIconacy Orthopedic Implants, LLC
Decision Date2013-08-09
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ICONACY I-HIP SYSTEM 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 2013-08-09 under 510(k) number K131279. 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 I-HIP SYSTEM?

ICONACY I-HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-09. The listed applicant is Iconacy Orthopedic Implants, LLC. The 510(k) number is K131279.

When did ICONACY I-HIP SYSTEM receive FDA 510(k) clearance?

ICONACY I-HIP SYSTEM received FDA 510(k) clearance on 2013-08-09, under 510(k) number K131279.

Who is the listed applicant for ICONACY I-HIP SYSTEM?

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 I-HIP SYSTEM?

The FDA product code for ICONACY I-HIP SYSTEM is LPH.

Related Clinical Trials

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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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)K151307ICONACY(TM) I-Hip (TM)K121034IOI TOTAL HIP

Related Devices (Code: LPH)

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.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, 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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