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510(k) K193038

Comprehensive Shoulder System by Biomet Manufacturing Corp — Product Code MBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2020
Date Received
October 31, 2019
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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  • K173411 — Comprehensive Segmental Revision System (SRS) (February 8, 2018)
  • K172502 — Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Co (January 3, 2018)
  • K163651 — ExpressBraid Graft Manipulation (February 17, 2017)
  • K152754 — COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) (May 16, 2016)

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