510(k) K021522

LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW by Walter Lorenz Surgical, Inc. — Product Code DZL

K021522 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW". The FDA issued a decision of Substantially Equivalent on May 21, 2002. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2002
Date Received
May 10, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type