The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Steinhauser Titanium Mini Bone Plates & Screws.
| Device ID | K862482 |
| 510k Number | K862482 |
| Device Name: | STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS |
| Classification | Plate, Bone |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Debra Powers |
| Correspondent | Debra Powers 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 | 1986-06-30 |
| Decision Date | 1986-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154619849 | K862482 | 000 |
| 07613154126682 | K862482 | 000 |
| 04546540174680 | K862482 | 000 |
| 04546540174673 | K862482 | 000 |