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FDA 510(k)

Trident II Acetabular System

K-Number: K191358 · 2019-10-24

ApplicantHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Decision Date2019-10-24
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Trident II Acetabular System is a medical device manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2019-10-24 under approval number K191358. 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 Acetabular System?

Trident II Acetabular System is a medical device that received FDA 510(k) clearance on 2019-10-24. It is manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K191358.

When was Trident II Acetabular System approved by the FDA?

Trident II Acetabular System received FDA 510(k) clearance on 2019-10-24, under approval number K191358.

What company makes Trident II Acetabular System?

Trident II Acetabular System is manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics.

What is the FDA product code for Trident II Acetabular System?

The FDA product code for Trident II Acetabular System is LPH.

Related Clinical Trials

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT02999009 Trident II Tritanium Acetabular Shell Outcomes Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018)

Other Devices by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components K171768Trident® II Acetabular System K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System K203099Triathlon PKR System

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Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, 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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