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510(k) K071676

EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS by Exactech, Inc. — Product Code KWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2007
Date Received
June 19, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3310
Review Panel
OR
Submission Type

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