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510(k) K212187

Restoration® Modular Hip System by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2022
Date Received
July 13, 2021
Clearance Type
Traditional
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

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  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)

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