HAX · Class II · 21 CFR 882.5960

FDA Product Code HAX: Tong, Skull For Traction

Leading manufacturers include Progress Mankind Technology, Jerome Medical and Orthopedic Systems, Inc..

20
Total
20
Cleared
155d
Avg days
1979
Since

FDA 510(k) Cleared Tong, Skull For Traction Devices (Product Code HAX)

20 devices
1–20 of 20
Cleared Jul 28, 2009
PMT HALO SYSTEM
K090733
Pmt Corp.
Neurology · 131d
Cleared May 25, 2007
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
K071173
Ossur Americans (Formerly the Jerome Group)
Neurology · 28d
Cleared Aug 17, 2005
RESOLVE OPEN BACK HALO RINGS
K051918
Jerome Medical
Neurology · 33d
Cleared Feb 21, 2003
JEROME GLASS RING
K023959
The Jerome Group, Inc.
Neurology · 86d
Cleared Jul 09, 2001
SPINE WORKS COLLAR
K003662
Spine Works
Neurology · 223d
Cleared Feb 18, 1999
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
K980689
Friddle'S Orthopedic Appliances, Inc.
Neurology · 360d
Cleared Dec 06, 1995
J TONGS
K930021
Jerome Medical
Neurology · 1065d
Cleared Oct 12, 1995
ACE CERVICAL TRACTION HALOZS, TONGS & PINS
K954069
Ace Medical Co.
Orthopedic · 43d
Cleared Sep 09, 1993
BREMER IMAGING TONGS-MRI MODEL
K924606
Bremer Medical, Inc.
Neurology · 363d
Cleared Aug 17, 1992
NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE
K915530
American Threshold Industries, Inc.
Neurology · 251d
Cleared Feb 05, 1988
LEVTECH COMPOSITE TRACTION TONGS
K873693
Levtech, Inc.
Neurology · 144d
Cleared Jun 19, 1987
PMT TRACTION TONGS
K871663
Progress Mankind Technology
Neurology · 52d
Cleared Dec 22, 1986
BREMER HALO SYSTEM
K864746
Bremer Orthopedics
Neurology · 17d
Cleared May 02, 1986
#CTO 100 (CERVICAL TRACTION ORTHOSIS 100)
K861470
Applied Medical Systems
Neurology · 10d
Cleared Aug 08, 1985
MAYFIELD DISPOSABLE SKULL PINS
K853066
Codman & Shurtleff, Inc.
Neurology · 20d
Cleared Sep 04, 1984
ACE UNIVERSAL TONG
K842680
Buckman Co., Inc.
Neurology · 56d
Cleared Feb 17, 1984
PMT-HALO/ORTHOPEDIC JACKET SYSTEM
K834047
Progress Mankind Technology
Neurology · 86d
Cleared Nov 22, 1982
HALO TRACTION CERVICAL IMMOBILIZATION
K822885
Orthopedic Systems, Inc.
Neurology · 55d
Cleared Dec 31, 1979
HALO SUPPORT JACKET & ASSOC. HARDWARE
K792586
Depuy, Inc.
Neurology · 14d

About Product Code HAX - Regulatory Context