The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Non-locking Bone Fixation System.
| Device ID | K090975 |
| 510k Number | K090975 |
| Device Name: | DEROYAL NON-LOCKING BONE FIXATION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Gracie Greenway |
| Correspondent | Gracie Greenway DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-06 |
| Decision Date | 2010-04-12 |