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 |