510(k) K903810

ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW by Ace Medical Co. — Product Code HWC

K903810 is an FDA 510(k) premarket notification submitted by Ace Medical Co. for the device "ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW". The FDA issued a decision of SN on October 16, 1990. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Ace Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
October 16, 1990
Date Received
August 20, 1990
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