SPINE WORKS COLLAR
Device Facts
| Record ID | K003662 |
|---|---|
| Device Name | SPINE WORKS COLLAR |
| Applicant | Spine Works |
| Product Code | HAX · Neurology |
| Decision Date | Jul 9, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5960 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.
