The following data is part of a premarket notification filed by Mecron Medical Products, Inc. with the FDA for Bone Plates.
| Device ID | K843553 |
| 510k Number | K843553 |
| Device Name: | BONE PLATES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | MECRON MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-10 |
| Decision Date | 1984-10-01 |