510(k) K962236

SCARF THREAD-HEAD SCREW by Landos, Inc. — Product Code HWC

K962236 is an FDA 510(k) premarket notification submitted by Landos, Inc. for the device "SCARF THREAD-HEAD SCREW". The FDA issued a decision of Substantially Equivalent on September 20, 1996. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Landos, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1996
Date Received
June 11, 1996
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