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510(k) K162068

ARROW Anatomical Porous glenoid by Fournitures Hospitalieres Industrie — Product Code MBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2017
Date Received
July 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3670
Review Panel
OR
Submission Type

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