Product code HAX— Neurology
#CTO 100 (CERVICAL TRACTION ORTHOSIS 100)
- Classification name
- Tong, Skull For Traction
- Device class
- Class 2
- Regulation
- 21 CFR 882.5960
- Advisory panel
- Neurology
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code HAX
FDA has cleared devices under product code HAX between 1979 and 2009, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2009
- 2007
- 2005
- 2003
- 2001
- 1999
- 1995
- 1993
- 1992
- 1988
- 1987
- 1986
- 1985
- 1984
- 1982
Top applicants under product code HAX
Recent clearances under product code HAX
- K090733 — PMT HALO SYSTEM
- K071173 — RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
- K051918 — RESOLVE OPEN BACK HALO RINGS
- K023959 — JEROME GLASS RING
- K003662 — SPINE WORKS COLLAR
- K980689 — FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
- K930021 — J TONGS
- K954069 — ACE CERVICAL TRACTION HALOZS, TONGS & PINS
- K924606 — BREMER IMAGING TONGS-MRI MODEL
- K915530 — NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE
- K873693 — LEVTECH COMPOSITE TRACTION TONGS
- K871663 — PMT TRACTION TONGS
- K864746 — BREMER HALO SYSTEM
- K861470 — #CTO 100 (CERVICAL TRACTION ORTHOSIS 100)
- K853066 — MAYFIELD DISPOSABLE SKULL PINS
- K842680 — ACE UNIVERSAL TONG
- K834047 — PMT-HALO/ORTHOPEDIC JACKET SYSTEM
- K822885 — HALO TRACTION CERVICAL IMMOBILIZATION
- K810193 — TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG
- K792586 — HALO SUPPORT JACKET & ASSOC. HARDWARE
Data sourced from openFDA. This site is unofficial and independent of the FDA.