FDA.reportPublic FDA data

510(k) K013132

Device
SIGN IM NAIL
Applicant
Surgical Implant Generation Network (Sign)
510(k) number
K013132
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2001-12-20
Date received
2001-09-19
Regulation
888.3020
Classification name
Rod, Fixation, Intramedullary And Accessories
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
DOUG DONNELLY
Address
2950 George Washington Way Richland WA US 99352 99352

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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