The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for Guide To The Knee.
| Device ID | K843121 |
| 510k Number | K843121 |
| Device Name: | GUIDE TO THE KNEE |
| Classification | Table And Attachments, Operating-room |
| Applicant | DYONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BWN |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-08 |
| Decision Date | 1984-09-07 |