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510(k) K171858

Sidus Stem-Free Shoulder by Zimmer GmbH — Product Code PKC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2017
Date Received
June 21, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Replacement of the humeral head for total anatomic shoulder arthroplasty

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