The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz 2.4 Self Drilling Screws.
| Device ID | K032228 |
| 510k Number | K032228 |
| Device Name: | LORENZ 2.4 SELF DRILLING SCREWS |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-08-11 |
| Summary: | summary |