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
101-125 of 411
Cleared Apr 13, 2006
NORIAN CRS FAST SET PUTTY
K060443 · GXP
Neurology · 51d
Cleared Apr 13, 2006
NORIAN CRS BONE CEMENT
K060445 · GXP
Neurology · 51d
Cleared Mar 21, 2006
NORIAN SRS BONE VOID FILLER
K060408 · MQV
Orthopedic · 33d
Cleared Mar 20, 2006
NORIAN SRS FAST SET PUTTY
K060406 · MQV
Orthopedic · 32d
Cleared Jan 23, 2006
SYNTHES (USA) CHRONOS-BETA-TCP
K053022 · LYC
Dental · 89d
Cleared Dec 14, 2005
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K053199 · GXN
Neurology · 28d
Cleared Dec 05, 2005
SYNTHES (USA) STERNAL FIXATION SYSTEM
K052683 · HRS
Orthopedic · 68d
Cleared Dec 02, 2005
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP
K053105 · HSB
Orthopedic · 28d
Cleared Nov 04, 2005
SYNTHES (USA) SPHERICAL WASHERS
K052483 · NDG
Orthopedic · 56d
Cleared Oct 12, 2005
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)
K052677 · HRS
Orthopedic · 14d
Cleared Oct 07, 2005
SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
K052390 · HRS
Orthopedic · 37d
Cleared Oct 05, 2005
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
K051879 · FTM
General & Plastic Surgery · 86d
Cleared Sep 23, 2005
SYNTHES PANGEA SYSTEM
K052123 · KWP
Orthopedic · 49d
Cleared Sep 21, 2005
SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM
K051678 · HSB
Orthopedic · 90d
Cleared Sep 08, 2005
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
K051986 · HRS
Orthopedic · 48d
Cleared Jul 27, 2005
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
K051600 · KTT
Orthopedic · 41d
Cleared Jul 25, 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720 · FMF
General Hospital · 28d
Cleared Jul 13, 2005
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
K051049 · KTT
Orthopedic · 79d
Cleared May 27, 2005
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
K042606 · GAQ
General & Plastic Surgery · 245d
Cleared May 18, 2005
SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
K050608 · JEY
Dental · 69d
Cleared Apr 27, 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683 · HWC
Orthopedic · 41d
Cleared Apr 26, 2005
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K050646 · HRS
Orthopedic · 43d
Cleared Apr 21, 2005
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
K050636 · HWC
Orthopedic · 41d
Cleared Apr 12, 2005
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
K043555 · MQN
Dental · 106d
Cleared Apr 11, 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
K050607 · HRS
Orthopedic · 32d

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