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510(k) K897141

Device
SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO
Applicant
STUART
510(k) number
K897141
Product code
JDN  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1990-06-21
Date received
1989-12-27
Regulation
888.3060
Classification name
Implant, Fixation Device, Spinal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ABRAHAM GLASSER
Address
One Stuart Plz. Donohue/Luxor Rd.S Greensburg PA US 15601 15601

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JDN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954856CANNULATED FEMORAL NAILSynthes (Usa)1996-03-08
K894184BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEMBiedermann Motech GmbH1990-04-25
K872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYRoseburg SA1987-12-07
K873977NEW C-D SYSTEM FOR SPINAL SURGERYSofamor Co.1987-12-07
K760649TOTAL SPINAL CORRECTIONDepuy, Inc.1976-10-05

Legacy Summary#

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FDA Review#

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