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
411 devices
226-250 of 411
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 20, 2002
SYNTHES CRANIAL PLATES
K020087 · JEY
Dental · 41d
Cleared Feb 08, 2002
SYNTHES METALLIC SPIKED WASHERS
K013806 · HTN
Orthopedic · 85d
Cleared Feb 07, 2002
FAST SET PUTTY
K012589 · GXP
Neurology · 181d
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
Cleared Dec 20, 2001
NORIAN SRS BONE VOID FILLER
K011897 · MQV
Orthopedic · 185d
Cleared Dec 19, 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248 · HRS
Orthopedic · 82d
Cleared Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · HWC
Orthopedic · 90d
Cleared Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · HWC
Orthopedic · 84d
Cleared Sep 28, 2001
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
K012114 · HRS
Orthopedic · 84d
Cleared Sep 12, 2001
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
K011857 · HSB
Orthopedic · 90d
Cleared Sep 06, 2001
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · KTW
Orthopedic · 87d
Cleared Aug 09, 2001
SYNTHES LCP PROXIMAL TIBIA PLATE
K011978 · HRS
Orthopedic · 45d
Cleared Aug 02, 2001
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
K011458 · KTW
Orthopedic · 83d
Cleared Jul 27, 2001
SYNTHES CURVED RECONSTRUCTION PLATE
K011334 · HRS
Orthopedic · 86d
Cleared Jul 27, 2001
SYNTHS ONE-THIRD TUBULAR DCL PLATE
K011335 · HRS
Orthopedic · 86d
Cleared Jul 19, 2001
SYNTHES CERVIFIX SYSTEM
K011969 · KWP
Orthopedic · 24d
Cleared Jul 05, 2001
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
K011170 · HRS
Orthopedic · 79d
Cleared Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
K010943 · JDQ
Orthopedic · 90d
Cleared Jun 27, 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034 · KTT
Orthopedic · 83d
Cleared Jun 12, 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766 · KTT
Orthopedic · 90d

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