510(k) K073426

APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM by Cayenne Medical, Inc. — Product Code HWC

K073426 is an FDA 510(k) premarket notification submitted by Cayenne Medical, Inc. for the device "APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM". The FDA issued a decision of Substantially Equivalent on February 19, 2008. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Cayenne Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2008
Date Received
December 5, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type