The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Self-drilling Imf Screw.
| Device ID | K040983 |
| 510k Number | K040983 |
| Device Name: | LORENZ SELF-DRILLING IMF SCREW |
| Classification | Implant, Endosseous, Root-form |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Kim Reed |
| Correspondent | Kim Reed WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-15 |
| Decision Date | 2004-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036094133 | K040983 | 000 |
| 00841036090784 | K040983 | 000 |
| 00841036090777 | K040983 | 000 |
| 00841036090760 | K040983 | 000 |
| 00841036090715 | K040983 | 000 |
| 00841036084806 | K040983 | 000 |
| 00841036084790 | K040983 | 000 |
| 00841036084783 | K040983 | 000 |