The following data is part of a premarket notification filed by Lossing Orthopedic, Inc. with the FDA for Cottrell 90/90 Backtrac.
| Device ID | K802555 |
| 510k Number | K802555 |
| Device Name: | COTTRELL 90/90 BACKTRAC |
| 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 | 1980-10-16 |
| Decision Date | 1980-10-31 |