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FDA 510(k)

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

K-Number: K161569 · 2016-10-14

ApplicantHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Decision Date2016-10-14
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

When was Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws approved by the FDA?

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

What company makes 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 manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics.

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.

Related Clinical Trials

NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING NCT07515092 Virtual Reality-Based Simulation Training for Antegrade Anterior Column Acetabular Screw Placement in Orthopedic Residents ENROLLING_BY_INVITATION NCT02999009 Trident II Tritanium Acetabular Shell Outcomes Study ACTIVE_NOT_RECRUITING

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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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