The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Halo Traction Cervical Immobilization.
| Device ID | K822885 |
| 510k Number | K822885 |
| Device Name: | HALO TRACTION CERVICAL IMMOBILIZATION |
| Classification | Tong, Skull For Traction |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-28 |
| Decision Date | 1982-11-22 |