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510(k) K060535

SPACER-S TEMPORARY SHOULDER SPACER by Tecres S.P.A. — Product Code HSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2006
Date Received
February 28, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class
Class II
Regulation Number
888.3690
Review Panel
OR
Submission Type

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