The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz 1.5 X 4 Mm Lactosorb Tap Free Screw.
Device ID | K021522 |
510k Number | K021522 |
Device Name: | LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW |
Classification | Screw, Fixation, Intraosseous |
Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Contact | Sheryl Malmberg |
Correspondent | Sheryl Malmberg WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Product Code | DZL |
CFR Regulation Number | 872.4880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-10 |
Decision Date | 2002-05-21 |
Summary: | summary |