FDA 510(k)

DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER

K-Number: K061547 · 2006-07-03

Decision Date2006-07-03

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2006-07-03 under 510(k) number K061547. 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 DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER?

DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER is a medical device that received FDA 510(k) clearance on 2006-07-03. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K061547.

When did DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER receive FDA 510(k) clearance?

DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER received FDA 510(k) clearance on 2006-07-03, under 510(k) number K061547.

Who is the listed applicant for DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER?

The FDA 510(k) record lists Wrightmedicaltechnologyinc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER?

The FDA product code for DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER 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.