Atlas FDA

HAX

20 FDA 510(k) clearances · Product code

56 daysmedian time to decision
363 days90th percentile
20clearances measured

FDA profile

Official device name
Tong, Skull For Traction
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5960
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
1997: 3 · 1998: 4 · 1999: 1 · 2001: 2 · 2002: 3 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PMT HALO SYSTEM (K090733)Pmt Corp.2009-07-28
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D (K071173)Ossur Americans (Formerly the Jerome Group)2007-05-25
RESOLVE OPEN BACK HALO RINGS (K051918)Jerome Medical2005-08-17
JEROME GLASS RING (K023959)The Jerome Group, Inc.2003-02-21
SPINE WORKS COLLAR (K003662)Spine Works2001-07-09
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM (K980689)Friddle'S Orthopedic Appliances, Inc.1999-02-18
J TONGS (K930021)Jerome Medical1995-12-06
ACE CERVICAL TRACTION HALOZS, TONGS & PINS (K954069)Ace Medical Co.1995-10-12
BREMER IMAGING TONGS-MRI MODEL (K924606)Bremer Medical, Inc.1993-09-09
NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (K915530)American Threshold Industries, Inc.1992-08-17
LEVTECH COMPOSITE TRACTION TONGS (K873693)Levtech, Inc.1988-02-05
PMT TRACTION TONGS (K871663)Progress Mankind Technology1987-06-19
BREMER HALO SYSTEM (K864746)Bremer Orthopedics1986-12-22
#CTO 100 (CERVICAL TRACTION ORTHOSIS 100) (K861470)Applied Medical Systems1986-05-02
MAYFIELD DISPOSABLE SKULL PINS (K853066)Codman & Shurtleff, Inc.1985-08-08
ACE UNIVERSAL TONG (K842680)Buckman Co., Inc.1984-09-04
PMT-HALO/ORTHOPEDIC JACKET SYSTEM (K834047)Progress Mankind Technology1984-02-17
HALO TRACTION CERVICAL IMMOBILIZATION (K822885)Orthopedic Systems, Inc.1982-11-22
TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG (K810193)Ace Orthopedic Manufacturing Co.1981-03-20
HALO SUPPORT JACKET & ASSOC. HARDWARE (K792586)Depuy, Inc.1979-12-31

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Every clearance here is in the API, with alerts when new ones post.