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
176-200 of 318
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
Cleared Jun 04, 2001
MODIFIED USS FRACTURE SYSTEM
K010658 · MNI
Orthopedic · 90d
Cleared May 30, 2001
SYNTHES RESORABLE MESHES AND SHEETS
K003788 · HRS
Orthopedic · 173d
Cleared May 23, 2001
SYNTHES ANTEROLATERAL CALCANEAL PLATE
K010518 · KTT
Orthopedic · 90d
Cleared May 03, 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
K010344 · KTT
Orthopedic · 87d
Cleared May 02, 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321 · KTW
Orthopedic · 89d
Cleared Apr 23, 2001
SYNTHES SYNMESH SPACER SYSTEM
K003275 · MQP
Orthopedic · 186d
Cleared Apr 09, 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · HTY
Orthopedic · 144d
Cleared Feb 20, 2001
SYNTHES HAMSTRING LOOP
K003700 · HWC
Orthopedic · 81d
Cleared Feb 09, 2001
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
K003743 · MAI
Orthopedic · 67d

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