FDA 510(k)

Restoration Anatomic Shell

K-Nummer: K210893 · 2021-04-22

AntragstellerHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

Entscheidungsdatum2021-04-22

ProduktcodeLPH

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Restoration Anatomic Shell is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2021-04-22 under 510(k) number K210893. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Restoration Anatomic Shell?

Restoration Anatomic Shell is a medical device that received FDA 510(k) clearance on 2021-04-22. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K210893.

When did Restoration Anatomic Shell receive FDA 510(k) clearance?

Restoration Anatomic Shell received FDA 510(k) clearance on 2021-04-22, under 510(k) number K210893.

Who is the listed applicant for Restoration Anatomic Shell?

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

What is the FDA product code for Restoration Anatomic Shell?

The FDA product code for Restoration Anatomic Shell is LPH.

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Verwandte Geräte (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.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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