Product Code: HAX FDA class 2 21 CFR 882.5960

Tong, Skull For Traction

Neurology

The Skull Tong for Traction is a clamping device applied to the outer table of the skull to apply continuous cervical traction, used in the management of cervical spine injuries, fractures, or dislocations to stabilize the spine and reduce deformity. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HAX under regulation 21 CFR 882.5960 in the Neurology specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code HAX in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: HAX
Device Class: FDA class 2
Regulation Number: 882.5960
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K090733	PMT HALO SYSTEM	Jul 28, 2009	Substantially Equivalent	Pmt Corp.
K071173	RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D	May 25, 2007	Substantially Equivalent	Ossur Americans (Formerly the Jerome Group)
K051918	RESOLVE OPEN BACK HALO RINGS	Aug 17, 2005	Substantially Equivalent	Jerome Medical
K023959	JEROME GLASS RING	Feb 21, 2003	Substantially Equivalent	The Jerome Group, Inc.
K003662	SPINE WORKS COLLAR	Jul 09, 2001	Substantially Equivalent	Spine Works
K980689	FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM	Feb 18, 1999	Substantially Equivalent	Friddle'S Orthopedic Appliances, Inc.
K930021	J TONGS	Dec 06, 1995	Substantially Equivalent	Jerome Medical
K954069	ACE CERVICAL TRACTION HALOZS, TONGS & PINS	Oct 12, 1995	Substantially Equivalent	Ace Medical Co.
K924606	BREMER IMAGING TONGS-MRI MODEL	Sep 09, 1993	Substantially Equivalent	Bremer Medical, Inc.
K915530	NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE	Aug 17, 1992	Substantially Equivalent	American Threshold Industries, Inc.
K873693	LEVTECH COMPOSITE TRACTION TONGS	Feb 05, 1988	Substantially Equivalent	Levtech, Inc.
K871663	PMT TRACTION TONGS	Jun 19, 1987	Substantially Equivalent	Progress Mankind Technology
K864746	BREMER HALO SYSTEM	Dec 22, 1986	Substantially Equivalent	Bremer Orthopedics
K861470	#CTO 100 (CERVICAL TRACTION ORTHOSIS 100)	May 02, 1986	Substantially Equivalent	Applied Medical Systems
K853066	MAYFIELD DISPOSABLE SKULL PINS	Aug 08, 1985	Substantially Equivalent	Codman & Shurtleff, Inc.
K842680	ACE UNIVERSAL TONG	Sep 04, 1984	Substantially Equivalent	Buckman Co., Inc.
K834047	PMT-HALO/ORTHOPEDIC JACKET SYSTEM	Feb 17, 1984	Substantially Equivalent	Progress Mankind Technology
K822885	HALO TRACTION CERVICAL IMMOBILIZATION	Nov 22, 1982	Substantially Equivalent	Orthopedic Systems, Inc.
K810193	TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG	Mar 20, 1981	Substantially Equivalent	Ace Orthopedic Manufacturing Co.
K792586	HALO SUPPORT JACKET & ASSOC. HARDWARE	Dec 31, 1979	Substantially Equivalent	Depuy, Inc.