Medical Device Manufacturer · US , Plainville , MA

Endius, Inc. - FDA 510(k) Cleared Devices

33 submissions · 33 cleared · Since 1997
33
Total
33
Cleared
0
Denied
FDA 510(k) Regulatory Record - Endius, Inc. Orthopedic ✕
28 devices
1-12 of 28
Cleared Mar 10, 2008
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION...
K080258 · NKB
Orthopedic · 39d
Cleared Feb 11, 2008
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
K073510 · NKB
Orthopedic · 60d
Cleared Jan 30, 2008
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K073267 · NKB
Orthopedic · 71d
Cleared Dec 07, 2007
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K072840 · NKB
Orthopedic · 64d
Cleared Sep 06, 2007
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K070282 · NKB
Orthopedic · 220d
Cleared Apr 12, 2007
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K070367 · NKB
Orthopedic · 63d
Cleared Jun 06, 2006
MODIFICATION TO ENDIUS ATAVI SYSTEM
K061345 · HRX
Orthopedic · 22d
Cleared Apr 26, 2006
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
K060990 · NKB
Orthopedic · 16d
Cleared Apr 18, 2006
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K060683 · KWP
Orthopedic · 34d
Cleared Jan 13, 2006
ENDIUS ATAVI SYSTEM
K053267 · HRX
Orthopedic · 51d
Cleared Oct 01, 2004
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K041808 · KWP
Orthopedic · 87d
Cleared Oct 02, 2002
ENDIUS ATAVI SYSTEM
K022199 · HRX
Orthopedic · 89d
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All33 Orthopedic 28 General & Plastic Surgery 2 Neurology 1 Gastroenterology & Urology 1 Ear, Nose, Throat 1