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510(k) K201315

PERFORM Humeral System – Stem by Tornier, Inc. — Product Code PAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2020
Date Received
May 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.

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