510(k) K033740

LORENZ STERNAL CLOSURE SYSTEM by Walter Lorenz Surgical, Inc. — Product Code HWC

K033740 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "LORENZ STERNAL CLOSURE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 15, 2003. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2003
Date Received
November 28, 2003
Clearance Type
Special
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