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
326-350 of 411
Cleared Oct 16, 1997
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K971883 · KWQ
Orthopedic · 147d
Cleared Oct 16, 1997
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017 · KTT
Orthopedic · 64d
Cleared Sep 04, 1997
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
K972516 · JDS
Orthopedic · 59d
Cleared Aug 01, 1997
SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)
K970048 · KWQ
Orthopedic · 207d
Cleared Jul 18, 1997
SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM
K971783 · HTY
Orthopedic · 65d
Cleared Jun 24, 1997
SMF TITANIUM (TI) ALLOY BONE SCREWS
K963546 · DZL
Dental · 292d
Cleared Jun 24, 1997
SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
K971987 · JEY
Dental · 26d
Cleared May 28, 1997
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K971544 · HWE
Orthopedic · 30d
Cleared May 09, 1997
SYNTHES (U.S.A.) POLYPIN
K961608 · HTY
Orthopedic · 379d
Cleared Apr 11, 1997
SMF STAINLESS STEEL BONE SCREWS
K964261 · DZL
Dental · 168d
Cleared Apr 02, 1997
SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM
K970733 · HTY
Orthopedic · 33d
Cleared Mar 25, 1997
SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K963325 · HRS
Orthopedic · 214d
Cleared Mar 17, 1997
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD...
K964416 · KWQ
Orthopedic · 164d
Cleared Mar 13, 1997
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
K970097 · JDW
Orthopedic · 59d
Cleared Feb 13, 1997
SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM
K963045 · MNH
Orthopedic · 192d
Cleared Jan 09, 1997
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL...
K963357 · MNH
Orthopedic · 136d
Cleared Jan 09, 1997
SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION
K964259 · JDO
Orthopedic · 76d
Cleared Dec 17, 1996
SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K962894 · HRS
Orthopedic · 145d
Cleared Dec 13, 1996
SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE
K964328 · JEY
Dental · 44d
Cleared Dec 09, 1996
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · MNH
Orthopedic · 159d
Cleared Nov 27, 1996
SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM
K963798 · HRS
Orthopedic · 65d
Cleared Nov 14, 1996
SYNTHES STERILE DRILL BITS
K962913 · HWE
Orthopedic · 111d
Cleared Nov 12, 1996
SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
K963618 · LXT
Orthopedic · 63d
Cleared Nov 08, 1996
SYNTHES STERILE 4.5 MM CANNULATED SCREWS
K963172 · HWC
Orthopedic · 86d
Cleared Nov 08, 1996
SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS
K963192 · HWC
Orthopedic · 85d

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