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
126-150 of 411
Cleared Apr 11, 2005
SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
K050631 · LXT
Orthopedic · 31d
Cleared Apr 06, 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
K050606 · DZL
Dental · 27d
Cleared Mar 16, 2005
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
K042899 · HTO
Orthopedic · 147d
Cleared Mar 15, 2005
SYNTHES MANDIBLE EXTERNAL FIXATOR
K050378 · MQN
Dental · 28d
Cleared Mar 04, 2005
SYNTHES (USA) LCP MODULAR FOOT PLATES
K050110 · HRS
Orthopedic · 45d
Cleared Mar 04, 2005
SYNTHES RAPID RESORBABLE TACK SYSTEM
K050204 · JEY
Dental · 35d
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 23, 2004
MODIFICATION TO SYNTHES CRANIAL PLATES
K042987 · JEY
Dental · 25d
Cleared Nov 18, 2004
SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM
K042365 · JEY
Dental · 79d
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) RAPID RESORBABLE CRANIAL CLAMP
K041611 · GXR
Neurology · 85d
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 Aug 27, 2004
SYNTHES (USA) TITANIUM WIRE
K041333 · GAQ
General & Plastic Surgery · 100d
Cleared Aug 19, 2004
SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS
K041887 · DZL
Dental · 38d

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