The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for T.o.d. Plate Sys Sterile.
| Device ID | K842695 |
| 510k Number | K842695 |
| Device Name: | T.O.D. PLATE SYS STERILE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | KIRSCHNER MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-11 |
| Decision Date | 1984-09-25 |