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HAX — Tong, Skull For Traction Class II

FDA Device Classification

Classification Details

Product Code
HAX
Device Class
Class II
Regulation Number
882.5960
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K090733pmtPMT HALO SYSTEMJuly 28, 2009
K071173ossur americans (formerly the jerome group)RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100DMay 25, 2007
K051918jerome medicalRESOLVE OPEN BACK HALO RINGSAugust 17, 2005
K023959jerome groupJEROME GLASS RINGFebruary 21, 2003
K003662spine worksSPINE WORKS COLLARJuly 9, 2001
K980689friddle orthopedic appliancesFRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEMFebruary 18, 1999
K930021jerome medicalJ TONGSDecember 6, 1995
K954069ace medicalACE CERVICAL TRACTION HALOZS, TONGS & PINSOctober 12, 1995
K924606bremer medicalBREMER IMAGING TONGS-MRI MODELSeptember 9, 1993
K915530american threshold industriesNOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILEAugust 17, 1992
K873693levtechLEVTECH COMPOSITE TRACTION TONGSFebruary 5, 1988
K871663progress mankind technologyPMT TRACTION TONGSJune 19, 1987
K864746bremer orthopedicsBREMER HALO SYSTEMDecember 22, 1986
K861470applied medical systems#CTO 100 (CERVICAL TRACTION ORTHOSIS 100)May 2, 1986
K853066codman and shurtleffMAYFIELD DISPOSABLE SKULL PINSAugust 8, 1985
K842680buckman coACE UNIVERSAL TONGSeptember 4, 1984
K834047progress mankind technologyPMT-HALO/ORTHOPEDIC JACKET SYSTEMFebruary 17, 1984
K822885orthopedic systemsHALO TRACTION CERVICAL IMMOBILIZATIONNovember 22, 1982
K810193ace orthopedic manufacturingTRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONGMarch 20, 1981
K792586depuyHALO SUPPORT JACKET & ASSOC. HARDWAREDecember 31, 1979