510(k) K982927

QUICK TAP SELF DRILLING SCREW by Kinamed, Inc. — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1998
Date Received
August 20, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type