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
101-125 of 318
Cleared Feb 25, 2005
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
K050041 · JDQ
Orthopedic · 49d
Cleared Feb 03, 2005
SYNTHES 3.5MM CORTEX SCREWS
K043185 · HWC
Orthopedic · 78d
Cleared Jan 18, 2005
SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
K043039 · KTT
Orthopedic · 75d
Cleared Jan 07, 2005
SYNTHES (USA) CHRONOS
K043045 · MQV
Orthopedic · 64d
Cleared Jan 05, 2005
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K043310 · HWE
Orthopedic · 35d
Cleared Nov 17, 2004
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
K042986 · GXR
Orthopedic · 19d
Cleared Nov 16, 2004
SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES
K042895 · KTT
Orthopedic · 27d
Cleared Oct 27, 2004
SYNTHES (USA) LCP WRIST FUSION PLATES
K042355 · HRS
Orthopedic · 57d
Cleared Oct 07, 2004
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)
K042135 · HSB
Orthopedic · 59d
Cleared Oct 07, 2004
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
K042356 · HWC
Orthopedic · 37d
Cleared Oct 07, 2004
SYNTHES LOW PROFILE RECONSTRUCTION PLATES
K042377 · HRS
Orthopedic · 36d
Cleared Sep 08, 2004
SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG
K041860 · HRS
Orthopedic · 61d
Cleared Sep 08, 2004
SYNTHES (USA) LCP CURVED PLATES
K041911 · KTT
Orthopedic · 55d
Cleared Sep 01, 2004
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
K041533 · HWC
Orthopedic · 85d
Cleared Jul 23, 2004
NORIAN SRS FAST SET PUTTY
K041842 · MQV
Orthopedic · 15d
Cleared Jun 18, 2004
LCP RADIAL HEAD PLATING SYSTEM
K040777 · HRS
Orthopedic · 84d
Cleared Jun 15, 2004
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
K040701 · HWC
Orthopedic · 90d
Cleared May 07, 2004
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
K040588 · HRS
Orthopedic · 63d
Cleared Apr 12, 2004
SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
K040336 · HSB
Orthopedic · 61d
Cleared Apr 12, 2004
SYNTHES (USA) TIBIAL NAIL SYSTEM EX
K040762 · JDS
Orthopedic · 18d
Cleared Apr 12, 2004
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
K040765 · JDW
Orthopedic · 18d
Cleared Mar 23, 2004
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
K040258 · KTT
Orthopedic · 48d
Cleared Mar 04, 2004
SYNTHES VENTROFIX MIS SYSTEM
K031100 · KWQ
Orthopedic · 332d
Cleared Mar 02, 2004
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
K033816 · JDQ
Orthopedic · 84d
Cleared Mar 01, 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · HWC
Orthopedic · 69d

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