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510k Database
Manufacturers
US
Trans1, Inc.
Medical Device Manufacturer
·
US , Excelsior , MN
Trans1, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2004
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Trans1, Inc.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 01, 2013
TRANS1LATERAL INTERBODY FUSION SYSTEM
K123997
·
MAX
Orthopedic
·
96d
Cleared
Dec 17, 2004
TRANS1 AXIAL FIXATION SYSTEM
K040426
·
KWQ
Orthopedic
·
302d
Cleared
Jan 15, 2004
TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
K032891
·
HRX
Orthopedic
·
120d
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Orthopedic
3