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510(k) K955099

SORBIE TOTAL ELBOW SYSTEM by Wrightmedicaltechnologyinc — Product Code JDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1996
Date Received
November 7, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Semi-Constrained, Cemented
Device Class
Class II
Regulation Number
888.3160
Review Panel
OR
Submission Type

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