FDA 510(k)

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws

K-Nummer: K161569 · 2016-10-14

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

Entscheidungsdatum2016-10-14

ProduktcodeLPH

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws 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 2016-10-14 under 510(k) number K161569. 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 Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws?

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K161569.

When did Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws receive FDA 510(k) clearance?

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161569.

Who is the listed applicant for Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws?

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 Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws?

The FDA product code for Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws is LPH.

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Verwandte Geräte (Code: LPH)

K261453G7® acetabulares 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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