Medical Device Manufacturer · US , West Chester , PA

Synthes Spine Co.Lp - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 2005

Recent clearances: SYNTHES ZERO-P VARIABLE ANGLE (VA), SYNTHES ZERO-P, SYNTHES ZERO-P VARIABLE ANGLE (VA)

18
Total
18
Cleared
0
Denied

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

18 devices
1-12 of 18
Cleared Jul 25, 2012
SYNTHES ZERO-P VARIABLE ANGLE (VA)
K121852 · OVE
Orthopedic · 30d
Cleared Dec 12, 2011
SYNTHES ZERO-P
K112459 · OVE
Orthopedic · 108d
Cleared Nov 07, 2011
SYNTHES ZERO-P VARIABLE ANGLE (VA)
K112068 · OVE
Orthopedic · 110d
Cleared Oct 20, 2011
SYNTHES XRL
K103320 · MQP
Orthopedic · 342d
Cleared Sep 02, 2008
ANTEGRA-T
K081568 · KWQ
Orthopedic · 90d
Cleared May 23, 2008
ARCOFIX
K080020 · KWQ
Orthopedic · 141d
Cleared Feb 11, 2008
SYNTHES ZERO-P
K072981 · OVE
Orthopedic · 111d
Cleared Jan 10, 2008
SYNTHES OC FUSION AND SYNAPSE SYSTEMS
K072434 · MNI
Orthopedic · 134d
Cleared Oct 12, 2007
SYNFIX-LR SPACER
K072253 · OVD
Orthopedic · 59d
Cleared Jun 08, 2007
SYNAPSE SYSTEM
K070573 · MNI
Orthopedic · 100d
Cleared Apr 03, 2007
SYNFIX -LR
K062083 · MQP
Orthopedic · 256d
Cleared Jan 31, 2007
SYNTHES ORACLE SPACER
K062933 · MQP
Orthopedic · 125d
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