The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil T-system Bone Screws.
| Device ID | K870141 |
| 510k Number | K870141 |
| Device Name: | URESIL T-SYSTEM BONE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Contact | Michael Jaron |
| Correspondent | Michael Jaron URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-13 |
| Decision Date | 1987-02-03 |