The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Ultra-micro Titanium Osteosynthesis System.
| Device ID | K910038 |
| 510k Number | K910038 |
| Device Name: | LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM |
| Classification | Plate, Bone |
| Applicant | WALTER LORENZ SURGICAL, INC. P.O. BOX 18009 Jacksonville, FL 32229 |
| Contact | Debra A Powers |
| Correspondent | Debra A Powers WALTER LORENZ SURGICAL, INC. P.O. BOX 18009 Jacksonville, FL 32229 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-04 |
| Decision Date | 1991-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036147549 | K910038 | 000 |
| 00888233012324 | K910038 | 000 |
| 00888233012348 | K910038 | 000 |
| 00888233012379 | K910038 | 000 |
| 00888233012393 | K910038 | 000 |
| 00888233005432 | K910038 | 000 |
| 00841036057442 | K910038 | 000 |
| 00841036057459 | K910038 | 000 |
| 00841036057466 | K910038 | 000 |
| 00841036057473 | K910038 | 000 |
| 00841036057480 | K910038 | 000 |
| 00841036128692 | K910038 | 000 |
| 00841036138776 | K910038 | 000 |
| 00841036140144 | K910038 | 000 |
| 00888233005456 | K910038 | 000 |