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510(k) K872715

Device
UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY
Applicant
ROSEBURG SA
510(k) number
K872715
Product code
JDN  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1987-12-07
Date received
1987-07-10
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
DARIENNE MOYER
Address
Suite 120 Canal Sq. 1054 31st St. NW Washington DC US 20007 20007

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
K897141SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIOStuart1990-06-21
K894184BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEMBiedermann Motech GmbH1990-04-25
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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