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FDA 510(k)

RESTORATION ACETABULAR WEDGE AUGMENTS

K-Number: K102019 · 2011-03-03

ApplicantHowmedica Osteonics
Decision Date2011-03-03
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RESTORATION ACETABULAR WEDGE AUGMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics. It received FDA 510(k) clearance on 2011-03-03 under 510(k) number K102019. 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 RESTORATION ACETABULAR WEDGE AUGMENTS?

RESTORATION ACETABULAR WEDGE AUGMENTS is a medical device that received FDA 510(k) clearance on 2011-03-03. The listed applicant is Howmedica Osteonics. The 510(k) number is K102019.

When did RESTORATION ACETABULAR WEDGE AUGMENTS receive FDA 510(k) clearance?

RESTORATION ACETABULAR WEDGE AUGMENTS received FDA 510(k) clearance on 2011-03-03, under 510(k) number K102019.

Who is the listed applicant for RESTORATION ACETABULAR WEDGE AUGMENTS?

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

What is the FDA product code for RESTORATION ACETABULAR WEDGE AUGMENTS?

The FDA product code for RESTORATION ACETABULAR WEDGE AUGMENTS is LPH.

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Other records listing Howmedica Osteonics as applicant

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K120578ACCOLADE II HIP STEMK063423TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERTK033258BONESAVE BONE VOID FILLERK032855STRYKER SPINE MAPS SYSTEMK031702REFLEX ANTERIOR CERVICAL PLATE SYSTEMK031435BONESOURCE BVF

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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