FDA 510(k)

ECHELON TITANIUM HIP SYSTEM

K-Number: K072817 · 2008-05-15

Decision Date2008-05-15

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ECHELON TITANIUM HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2008-05-15 under 510(k) number K072817. 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 ECHELON TITANIUM HIP SYSTEM?

ECHELON TITANIUM HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-15. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K072817.

When did ECHELON TITANIUM HIP SYSTEM receive FDA 510(k) clearance?

ECHELON TITANIUM HIP SYSTEM received FDA 510(k) clearance on 2008-05-15, under 510(k) number K072817.

Who is the listed applicant for ECHELON TITANIUM HIP SYSTEM?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHELON TITANIUM HIP SYSTEM?

The FDA product code for ECHELON TITANIUM HIP SYSTEM is LPH.

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Related Devices (Code: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 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 Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® 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.