510(k) K001989

COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES by Zimmer, Inc. — Product Code JDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2000
Date Received
June 29, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Constrained, Cemented
Device Class
Class II
Regulation Number
888.3150
Review Panel
OR
Submission Type