FDA.reportPublic FDA data

510(k) K003662

Device
SPINE WORKS COLLAR
Applicant
Spine Works
510(k) number
K003662
Product code
HAX
Decision
Substantially Equivalent (SESE)
Decision date
2001-07-09
Date received
2000-11-28
Regulation
882.5960
Classification name
Tong, Skull For Traction
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
DAN FARLEY
Address
10170 E Cherry Bend Rd. Traverse City MI US 49684 49684

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HAX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K090733PMT HALO SYSTEMPmt Corp.2009-07-28
K071173RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100DOssur Americans (Formerly the Jerome Group)2007-05-25
K051918RESOLVE OPEN BACK HALO RINGSJerome Medical2005-08-17
K023959JEROME GLASS RINGThe Jerome Group, Inc.2003-02-21
K980689FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEMFriddle'S Orthopedic Appliances, Inc.1999-02-18
K930021J TONGSJerome Medical1995-12-06
K954069ACE CERVICAL TRACTION HALOZS, TONGS & PINSAce Medical Co.1995-10-12
K924606BREMER IMAGING TONGS-MRI MODELBremer Medical, Inc.1993-09-09
K915530NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILEAmerican Threshold Industries, Inc.1992-08-17
K873693LEVTECH COMPOSITE TRACTION TONGSLevtech, Inc.1988-02-05
K871663PMT TRACTION TONGSProgress Mankind Technology1987-06-19
K864746BREMER HALO SYSTEMBremer Orthopedics1986-12-22
K861470#CTO 100 (CERVICAL TRACTION ORTHOSIS 100)Applied Medical Systems1986-05-02
K853066MAYFIELD DISPOSABLE SKULL PINSCodman & Shurtleff, Inc.1985-08-08
K842680ACE UNIVERSAL TONGBuckman Co., Inc.1984-09-04