FDA 510(k)

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

Numéro K : K161569 · 2016-10-14

DemandeurHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

Date de décision2016-10-14

Code produitLPH

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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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Dispositifs connexes (Code : LPH)

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Source officielle

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