The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Wuerzburg Titanium Mini Bone Plates & Bone Screws.
| Device ID | K854886 |
| 510k Number | K854886 |
| Device Name: | WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS |
| Classification | Plate, Bone |
| Applicant | WALTER LORENZ SURGICAL, INC. ADVANCED BIOSEARCH ASSOCIATES 1700 ROCKVILLE PIKE SUITE 320 Rockville, MD 20852 |
| Contact | Joel Faden |
| Correspondent | Joel Faden WALTER LORENZ SURGICAL, INC. ADVANCED BIOSEARCH ASSOCIATES 1700 ROCKVILLE PIKE SUITE 320 Rockville, MD 20852 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-06 |
| Decision Date | 1986-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036152710 | K854886 | 000 |
| 00841036152697 | K854886 | 000 |
| 00841036065638 | K854886 | 000 |
| 00841036058579 | K854886 | 000 |
| 00841036058562 | K854886 | 000 |
| 00841036058555 | K854886 | 000 |
| 00888233019231 | K854886 | 000 |
| 00888233019217 | K854886 | 000 |