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510(k) K853066

Device
Mayfield Disposable Skull Pins
Applicant
Codman & Shurtleff, Inc.
510(k) number
K853066
Product code
HAX
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-08
Date received
1985-07-19
Regulation
882.5960
Classification name
Tong, Skull For Traction
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
THOMAS J COURAGE
Address
41 Pacella Park Dr. Randolph Industrial Park Randolph MA US 02368 02368

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K003662SPINE WORKS COLLARSpine Works2001-07-09
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
K842680ACE UNIVERSAL TONGBuckman Co., Inc.1984-09-04