Medical Device Manufacturer · US , Mchenry , IL

Synthes (Usa) - FDA 510(k) Cleared Devices

411 submissions · 394 cleared · Since 1977
411
Total
394
Cleared
0
Denied
318 devices
151-175 of 318
Cleared Apr 01, 2003
SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
K030390 · LXT
Orthopedic · 55d
Cleared Mar 24, 2003
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
K022949 · MNI
Orthopedic · 200d
Cleared Mar 20, 2003
SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
K030597 · HRS
Orthopedic · 23d
Cleared Mar 17, 2003
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
K024364 · MQP
Orthopedic · 76d
Cleared Mar 06, 2003
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
K030377 · MNI
Orthopedic · 29d
Cleared Feb 05, 2003
SMALL TITANIUM WRIST FUSION PLATE
K023879 · HRS
Orthopedic · 76d
Cleared Jan 28, 2003
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
K023802 · HRS
Orthopedic · 75d
Cleared Jan 23, 2003
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K023941 · KTT
Orthopedic · 58d
Cleared Dec 19, 2002
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862 · MQV
Orthopedic · 29d
Cleared Nov 26, 2002
SYNTHES CERVIFIX/ AXON
K023675 · KWP
Orthopedic · 25d
Cleared Nov 13, 2002
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791 · KWQ
Orthopedic · 83d
Cleared Sep 06, 2002
SYNTHES 6.5 MM CANNULATED SCREW
K021932 · HWC
Orthopedic · 86d
Cleared Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556 · HWC
Orthopedic · 88d
Cleared Jul 25, 2002
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
K022255 · HRS
Orthopedic · 13d
Cleared Jul 24, 2002
SYNTHES IN-SITU BENDER/CUTTER
K021458 · HRS
Orthopedic · 78d
Cleared Jul 01, 2002
VERTEBRAL SPACER
K011037 · MQP
Orthopedic · 452d
Cleared Jun 12, 2002
SYNTHES 3.5 MM BROAD LC-DCP PLATES
K020872 · HRS
Orthopedic · 86d
Cleared May 08, 2002
SYNTHES CALCANEAL PLATE
K020401 · HRS
Orthopedic · 90d
Cleared Apr 16, 2002
SYNTHES VERTEBRAL SPACER TI
K020152 · MQP
Orthopedic · 89d
Cleared Apr 15, 2002
SYNTHES DUAL-OPENING USS
K020517 · MNI
Orthopedic · 55d
Cleared Mar 21, 2002
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE
K014197 · HRS
Orthopedic · 90d
Cleared Feb 08, 2002
SYNTHES METALLIC SPIKED WASHERS
K013806 · HTN
Orthopedic · 85d
Cleared Jan 30, 2002
SPIKED WASHER
K011583 · HTN
Orthopedic · 252d
Cleared Jan 11, 2002
SYNTHES ANKLE ARTHRODESIS PLATE
K013415 · HRS
Orthopedic · 88d
Cleared Dec 21, 2001
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
K013527 · HTO
Orthopedic · 59d

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