The following data is part of a premarket notification filed by Bregma International Trading Company Ltd. with the FDA for Bone Screws.
| Device ID | K990351 |
| 510k Number | K990351 |
| Device Name: | BONE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | BREGMA INTERNATIONAL TRADING COMPANY LTD. 214-111 RESEARCH DR. Saskatoon, Saskatchewan, CA S7n 3r2 |
| Contact | Assem Hedayat |
| Correspondent | Assem Hedayat BREGMA INTERNATIONAL TRADING COMPANY LTD. 214-111 RESEARCH DR. Saskatoon, Saskatchewan, CA S7n 3r2 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-05 |
| Decision Date | 1999-06-01 |