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489
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475
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436
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403
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Manufacturers
US
Orthofix
Medical Device Manufacturer
·
US , Lweisville , TX
Orthofix - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2012
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthofix
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 28, 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130176
·
NKB
Orthopedic
·
62d
Cleared
Dec 03, 2012
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
K122901
·
NKB
Orthopedic
·
73d
Cleared
Nov 29, 2012
CONSTRUX MINI PEEK TI SPACER SYSTEM
K121649
·
ODP
Orthopedic
·
177d
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Orthopedic
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