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510(k) K112905

COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM by Biomet Orthopedics, LLC — Product Code MBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2012
Date Received
October 3, 2011
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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Other clearances for product code MBF

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  • K213856 — Identity Shoulder System (September 15, 2022)