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510k Database
Manufacturers
US
Qualgenix
Medical Device Manufacturer
·
US , Oxford , CT
Qualgenix - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2012
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Qualgenix
Orthopedic
✕
2
devices
1-2 of 2
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Cleared
May 01, 2012
MONT BLANC PEDICLE SCREW SYSTEMS
K112684
·
NKB
Orthopedic
·
229d
Cleared
May 01, 2012
AYERS ROCK CERVICAL CAGE
K112801
·
ODP
Orthopedic
·
217d
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Orthopedic
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