The following data is part of a premarket notification filed by Kapp Surgical Instrument, Inc. with the FDA for Kapp Spinal Button.
| Device ID | K843368 |
| 510k Number | K843368 |
| Device Name: | KAPP SPINAL BUTTON |
| Classification | Washer, Bolt Nut |
| Applicant | KAPP SURGICAL INSTRUMENT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-28 |
| Decision Date | 1984-09-12 |