Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5960](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5960) → HAX — Tong, Skull For Traction # HAX · Tong, Skull For Traction _Neurology · 21 CFR 882.5960 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX ## Overview - **Product Code:** HAX - **Device Name:** Tong, Skull For Traction - **Regulation:** [21 CFR 882.5960](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5960) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## 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. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 20) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K090733](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K090733.md) | PMT HALO SYSTEM | Pmt Corp. | Jul 28, 2009 | SESE | | [K071173](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K071173.md) | RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D | Ossur Americans (Formerly the Jerome Group) | May 25, 2007 | SESE | | [K051918](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K051918.md) | RESOLVE OPEN BACK HALO RINGS | Jerome Medical | Aug 17, 2005 | SESE | | [K023959](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K023959.md) | JEROME GLASS RING | The Jerome Group, Inc. | Feb 21, 2003 | SESE | | [K003662](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K003662.md) | SPINE WORKS COLLAR | Spine Works | Jul 9, 2001 | SESE | | [K980689](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K980689.md) | FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM | Friddle'S Orthopedic Appliances, Inc. | Feb 18, 1999 | SESE | | [K930021](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K930021.md) | J TONGS | Jerome Medical | Dec 6, 1995 | SESE | | [K954069](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K954069.md) | ACE CERVICAL TRACTION HALOZS, TONGS & PINS | Ace Medical Co. | Oct 12, 1995 | SESE | | [K924606](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K924606.md) | BREMER IMAGING TONGS-MRI MODEL | Bremer Medical, Inc. | Sep 9, 1993 | SESE | | [K915530](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K915530.md) | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | American Threshold Industries, Inc. | Aug 17, 1992 | SESE | | [K873693](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K873693.md) | LEVTECH COMPOSITE TRACTION TONGS | Levtech, Inc. | Feb 5, 1988 | SESE | | [K871663](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K871663.md) | PMT TRACTION TONGS | Progress Mankind Technology | Jun 19, 1987 | SESE | | [K864746](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K864746.md) | BREMER HALO SYSTEM | Bremer Orthopedics | Dec 22, 1986 | SESE | | [K861470](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K861470.md) | #CTO 100 (CERVICAL TRACTION ORTHOSIS 100) | Applied Medical Systems | May 2, 1986 | SESE | | [K853066](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K853066.md) | MAYFIELD DISPOSABLE SKULL PINS | Codman & Shurtleff, Inc. | Aug 8, 1985 | SESE | | [K842680](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K842680.md) | ACE UNIVERSAL TONG | Buckman Co., Inc. | Sep 4, 1984 | SESE | | [K834047](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K834047.md) | PMT-HALO/ORTHOPEDIC JACKET SYSTEM | Progress Mankind Technology | Feb 17, 1984 | SESE | | [K822885](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K822885.md) | HALO TRACTION CERVICAL IMMOBILIZATION | Orthopedic Systems, Inc. | Nov 22, 1982 | SESE | | [K810193](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K810193.md) | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG | Ace Orthopedic Manufacturing Co. | Mar 20, 1981 | SESE | | [K792586](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX/K792586.md) | HALO SUPPORT JACKET & ASSOC. HARDWARE | Depuy, Inc. | Dec 31, 1979 | SESE | ## Top Applicants - Jerome Medical — 2 clearances - Progress Mankind Technology — 2 clearances - Ace Medical Co. — 1 clearance - Ace Orthopedic Manufacturing Co. — 1 clearance - American Threshold Industries, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HAX) **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. 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