Medical Device Manufacturer · US , Paoli , PA

Synthes Spine - FDA 510(k) Cleared Devices

36 submissions · 32 cleared · Since 1995

Recent clearances: SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS, SYNTHES MATRIX SYSTEM, SYNTHES SCOUT TACK FIXATION

36
Total
32
Cleared
0
Denied

FDA 510(k) Regulatory Record - Synthes Spine Orthopedic ✕

34 devices
1-12 of 34
Cleared Jul 31, 2012
SYNTHES MATRIX SYSTEM
K120838 · NKB
Orthopedic · 133d
Cleared Jun 14, 2012
SYNTHES SCOUT TACK FIXATION
K111048 · OMR
Orthopedic · 426d
Cleared May 18, 2012
SYNTHES MATRIX SYSTEM
K120928 · NKB
Orthopedic · 52d
Cleared May 14, 2012
SYNTHES USS CONNECTOR
K120571 · NKB
Orthopedic · 77d
Cleared Feb 01, 2012
SYNTHES USS CONNECTORS
K113149 · MNI
Orthopedic · 100d
Cleared Dec 21, 2011
SYNTHES MIRS
K113044 · NKB
Orthopedic · 70d
Cleared Nov 18, 2011
SYNTHES USS
K111358 · NKB
Orthopedic · 186d
Cleared Jan 05, 2011
SYNTHES 6.0 COCR AND CPT TI-3 RODS
K103287 · NKB
Orthopedic · 65d
Cleared Dec 20, 2010
SYNTHES ZERO-P
K093762 · OVE
Orthopedic · 378d
Cleared Aug 05, 2010
MODIFICATION TO SYNTHES MATRIX SYSTEM
K100952 · NKB
Orthopedic · 121d
Cleared May 13, 2010
SYNTHES T-PAL SPACER
K100089 · MAX
Orthopedic · 121d
Cleared Jul 10, 2009
SYNTHES ORACLE PLATE
K091159 · KWQ
Orthopedic · 80d
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