The following data is part of a premarket notification filed by Teknar, Inc. with the FDA for Axisonic Ii.
| Device ID | K810697 |
| 510k Number | K810697 |
| Device Name: | AXISONIC II |
| Classification | Cap, Cervical |
| Applicant | TEKNAR, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HDR |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-16 |
| Decision Date | 1981-07-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AXISONIC II 73423904 1285924 Dead/Cancelled |
Teknar, Inc. 1983-05-02 |