Home / 510(k) Clearances / K960087

510(k) K960087

SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) by Wrightmedicaltechnologyinc — Product Code JDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1996
Date Received
January 11, 1996
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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