The following data is part of a premarket notification filed by Lossing Orthopedic, Inc. with the FDA for Necktrac.
| Device ID | K813017 |
| 510k Number | K813017 |
| Device Name: | NECKTRAC |
| Classification | Apparatus, Traction, Non-powered |
| Applicant | LOSSING ORTHOPEDIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HST |
| CFR Regulation Number | 888.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-27 |
| Decision Date | 1981-11-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NECKTRAC 73360561 1243498 Dead/Cancelled |
Lossing Orthopedic Brace Co. 1982-04-19 |