510(k) K872156

CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM by Concept, Inc. — Product Code HWC

K872156 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on July 21, 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
July 21, 1987
Date Received
June 4, 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