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510(k) K213785

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid by Limacorporate — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2022
Date Received
December 6, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

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