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510k Database
Manufacturers
US
Dgimed Ortho, Inc.
Medical Device Manufacturer
·
US , Minnetonka , MN
Dgimed Ortho, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2009
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dgimed Ortho, Inc.
Orthopedic
✕
3
devices
1-3 of 3
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Cleared
Jan 06, 2014
DISTALOCK TIBIAL IM NAIL SYSTEM
K132830
·
HSB
Orthopedic
·
118d
Cleared
Apr 20, 2010
DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM
K100312
·
HSB
Orthopedic
·
75d
Cleared
Nov 05, 2009
REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX
K091309
·
HSB
Orthopedic
·
185d
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Orthopedic
3