510(k) K931680

CANNULATED CANCELLOUS SCREW by Onyx Medical Corp. — Product Code HWC

K931680 is an FDA 510(k) premarket notification submitted by Onyx Medical Corp. for the device "CANNULATED CANCELLOUS SCREW". The FDA issued a decision of SN on May 4, 1994. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Onyx Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 4, 1994
Date Received
April 5, 1993
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