The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz 1.0 Mm System.
| Device ID | K922741 |
| 510k Number | K922741 |
| Device Name: | LORENZ 1.0 MM SYSTEM |
| Classification | Plate, Bone |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Debra Powers |
| Correspondent | Debra Powers WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-08 |
| Decision Date | 1992-12-23 |