510(k) K871037

CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW by Concept, Inc. — Product Code HWC

K871037 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW". The FDA issued a decision of Substantially Equivalent on March 25, 1987. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Concept, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1987
Date Received
March 17, 1987
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