Medical Device Manufacturer · US , 19380 , PA

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

8 submissions · 8 cleared · Since 2011
8
Total
8
Cleared
0
Denied

Synthes, Inc. has 8 FDA 510(k) cleared medical devices. Based in 19380, US.

Historical record: 8 cleared submissions from 2011 to 2013. Primary specialty: Dental.

Browse the FDA 510(k) cleared devices submitted by Synthes, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Synthes, Inc.
8 devices
1-8 of 8
Cleared Dec 16, 2013
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
K131792 · GXQ
Neurology · 181d
Cleared Feb 28, 2013
SYNTHES PATIENT SPECIFIC PLATE
K122647 · JEY
Dental · 182d
Cleared Nov 19, 2012
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
K113567 · JEY
Dental · 353d
Cleared Aug 23, 2012
SYNTHES CURVILINEAR DISTRACTION SYSTEM
K121502 · MQN
Dental · 94d
Cleared Jun 29, 2012
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
K121574 · JEY
Dental · 30d
Cleared Dec 21, 2011
SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
K113251 · JEY
Dental · 48d
Cleared Nov 16, 2011
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
K111323 · KKY
General & Plastic Surgery · 189d
Cleared Oct 26, 2011
SYNTHES STERNAL FIXATION SYSTEM
K112689 · HRS
Orthopedic · 41d
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All8 Dental 5 General & Plastic Surgery 1 Neurology 1 Orthopedic 1