HAX · Tong, Skull For Traction
Neurology · 21 CFR 882.5960 · Class 2
Overview
| Product Code | HAX |
|---|---|
| Device Name | Tong, Skull For Traction |
| Regulation | 21 CFR 882.5960 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | PMT HALO SYSTEM | Pmt Corp. | Jul 28, 2009 | SESE |
| K071173 | RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D | Ossur Americans (Formerly the Jerome Group) | May 25, 2007 | SESE |
| K051918 | RESOLVE OPEN BACK HALO RINGS | Jerome Medical | Aug 17, 2005 | SESE |
| K023959 | JEROME GLASS RING | The Jerome Group, Inc. | Feb 21, 2003 | SESE |
| K003662 | SPINE WORKS COLLAR | Spine Works | Jul 9, 2001 | SESE |
| K980689 | FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM | Friddle'S Orthopedic Appliances, Inc. | Feb 18, 1999 | SESE |
| K930021 | J TONGS | Jerome Medical | Dec 6, 1995 | SESE |
| K954069 | ACE CERVICAL TRACTION HALOZS, TONGS & PINS | Ace Medical Co. | Oct 12, 1995 | SESE |
| K924606 | BREMER IMAGING TONGS-MRI MODEL | Bremer Medical, Inc. | Sep 9, 1993 | SESE |
| K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | American Threshold Industries, Inc. | Aug 17, 1992 | SESE |
| K873693 | LEVTECH COMPOSITE TRACTION TONGS | Levtech, Inc. | Feb 5, 1988 | SESE |
| K871663 | PMT TRACTION TONGS | Progress Mankind Technology | Jun 19, 1987 | SESE |
| K864746 | BREMER HALO SYSTEM | Bremer Orthopedics | Dec 22, 1986 | SESE |
| K861470 | #CTO 100 (CERVICAL TRACTION ORTHOSIS 100) | Applied Medical Systems | May 2, 1986 | SESE |
| K853066 | MAYFIELD DISPOSABLE SKULL PINS | Codman & Shurtleff, Inc. | Aug 8, 1985 | SESE |
| K842680 | ACE UNIVERSAL TONG | Buckman Co., Inc. | Sep 4, 1984 | SESE |
| K834047 | PMT-HALO/ORTHOPEDIC JACKET SYSTEM | Progress Mankind Technology | Feb 17, 1984 | SESE |
| K822885 | HALO TRACTION CERVICAL IMMOBILIZATION | Orthopedic Systems, Inc. | Nov 22, 1982 | SESE |
| K810193 | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG | Ace Orthopedic Manufacturing Co. | Mar 20, 1981 | SESE |
| K792586 | 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
