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510(k) K190595

Signature ONE System by Orthosoft Inc (D/B/A Zimmer Cas) — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2019
Date Received
March 7, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3650
Review Panel
OR
Submission Type

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