The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Orthodontic Anchorage System.
| Device ID | K063386 |
| 510k Number | K063386 |
| Device Name: | LORENZ ORTHODONTIC ANCHORAGE SYSTEM |
| Classification | Implant, Endosseous, Orthodontic |
| 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 | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-08 |
| Decision Date | 2007-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036163891 | K063386 | 000 |
| 00841036129903 | K063386 | 000 |
| 00841036133351 | K063386 | 000 |
| 00841036133368 | K063386 | 000 |
| 00841036163846 | K063386 | 000 |
| 00841036163853 | K063386 | 000 |
| 00841036163860 | K063386 | 000 |
| 00841036163877 | K063386 | 000 |
| 00841036163884 | K063386 | 000 |
| 00841036129897 | K063386 | 000 |