The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Resorbable Distraction System Or Expander.
| Device ID | K030425 |
| 510k Number | K030425 |
| Device Name: | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER |
| Classification | Plate, 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 | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-10 |
| Decision Date | 2004-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036159443 | K030425 | 000 |
| 00841036070274 | K030425 | 000 |
| 00841036071097 | K030425 | 000 |
| 00841036071103 | K030425 | 000 |
| 00841036071110 | K030425 | 000 |
| 00841036094287 | K030425 | 000 |
| 00841036095901 | K030425 | 000 |
| 00841036095956 | K030425 | 000 |
| 00841036126889 | K030425 | 000 |
| 00841036127770 | K030425 | 000 |
| 00841036159412 | K030425 | 000 |
| 00841036159429 | K030425 | 000 |
| 00841036159436 | K030425 | 000 |
| 00841036067687 | K030425 | 000 |