The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Reconstruction System With Modular Screw.
| Device ID | K980512 |
| 510k Number | K980512 |
| Device Name: | LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW |
| Classification | Plate, Bone |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Diana Preston |
| Correspondent | Diana Preston 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 | 1998-02-10 |
| Decision Date | 1998-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036150792 | K980512 | 000 |
| 00841036125912 | K980512 | 000 |
| 00841036125929 | K980512 | 000 |
| 00841036125936 | K980512 | 000 |
| 00841036125943 | K980512 | 000 |
| 00841036125950 | K980512 | 000 |
| 00841036125967 | K980512 | 000 |
| 00841036125974 | K980512 | 000 |
| 00841036125981 | K980512 | 000 |
| 00841036125998 | K980512 | 000 |
| 00841036126001 | K980512 | 000 |
| 00841036126018 | K980512 | 000 |
| 00841036126025 | K980512 | 000 |
| 00841036010362 | K980512 | 000 |