The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Self Drilling Screws.
| Device ID | K013954 |
| 510k Number | K013954 |
| Device Name: | LORENZ 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-30 |
| Decision Date | 2002-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036159221 | K013954 | 000 |
| 00841036057794 | K013954 | 000 |
| 00841036057787 | K013954 | 000 |
| 00841036057770 | K013954 | 000 |
| 00841036013639 | K013954 | 000 |
| 00841036013622 | K013954 | 000 |
| 00841036013615 | K013954 | 000 |
| 00888233020220 | K013954 | 000 |
| 00888233001618 | K013954 | 000 |
| 00841036073916 | K013954 | 000 |
| 00841036073923 | K013954 | 000 |
| 00841036154271 | K013954 | 000 |
| 00841036154196 | K013954 | 000 |
| 00841036089559 | K013954 | 000 |
| 00841036089320 | K013954 | 000 |
| 00841036089313 | K013954 | 000 |
| 00841036089306 | K013954 | 000 |
| 00841036089290 | K013954 | 000 |
| 00841036089214 | K013954 | 000 |
| 00888233001526 | K013954 | 000 |