The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Imf Screw.
| Device ID | K983728 |
| 510k Number | K983728 |
| Device Name: | LORENZ IMF SCREW |
| Classification | Screw, Fixation, Intraosseous |
| 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 | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-22 |
| Decision Date | 1999-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036199807 | K983728 | 000 |
| 00841036056629 | K983728 | 000 |
| 00841036053710 | K983728 | 000 |
| 00841036053703 | K983728 | 000 |
| 00888233021388 | K983728 | 000 |
| 00888233021371 | K983728 | 000 |
| 00888233021364 | K983728 | 000 |
| 00888233018357 | K983728 | 000 |
| 00888233018333 | K983728 | 000 |
| 00888233018319 | K983728 | 000 |
| 00888233001465 | K983728 | 000 |
| 00888233001458 | K983728 | 000 |
| 00841036056636 | K983728 | 000 |
| 00841036128098 | K983728 | 000 |
| 00841036128104 | K983728 | 000 |
| 00841036194413 | K983728 | 000 |
| 00841036194406 | K983728 | 000 |
| 00841036194390 | K983728 | 000 |
| 00841036168186 | K983728 | 000 |
| 00841036168179 | K983728 | 000 |
| 00841036163778 | K983728 | 000 |
| 00841036135423 | K983728 | 000 |
| 00841036130572 | K983728 | 000 |
| 00841036129750 | K983728 | 000 |
| 00841036129743 | K983728 | 000 |
| 00841036129736 | K983728 | 000 |
| 00888233001441 | K983728 | 000 |