← Product Code [HAX](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX) · K954069

# ACE CERVICAL TRACTION HALOZS, TONGS & PINS (K954069)

_Ace Medical Co. · HAX · Oct 12, 1995 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K954069

## Device Facts

- **Applicant:** Ace Medical Co.
- **Product Code:** [HAX](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX.md)
- **Decision Date:** Oct 12, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5960
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K954069](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K954069)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
