510(k) K024022

OSTEO-CABLE SLEEVE by Biomet, Inc. — Product Code HXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2003
Date Received
December 5, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Cerclage
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type