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510(k) K211703

Insignia Hip Stem by Stryker Orthopaedics — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2021
Date Received
June 3, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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