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510(k) K191358

Trident II Acetabular System by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2019
Date Received
May 21, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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

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  • K203099 — Triathlon PKR System (October 27, 2020)
  • K182468 — Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hi (March 19, 2019)
  • K180612 — Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts (June 7, 2018)
  • K172634 — Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components (November 16, 2017)
  • K171768 — Trident® II Acetabular System (October 2, 2017)
  • K161569 — Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws (October 14, 2016)

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