Medical Device Manufacturer · US , Mchenry , IL

United States Surgical, A Division of Tyco Healthc - FDA 510(k) Clear...

218 submissions · 200 cleared · Since 1977
218
Total
200
Cleared
0
Denied
FDA 510(k) Regulatory Record - United States Surgical, A Division of Tyco Healthc Orthopedic ✕
24 devices
1-12 of 24
Cleared Mar 31, 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · HWC
Orthopedic · 23d
Cleared Apr 15, 2002
SPIRAL RADIUS 90-D RODDING SYSTEM
K020134 · KWP
Orthopedic · 90d
Cleared Dec 11, 2001
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · HWC
Orthopedic · 18d
Cleared Aug 15, 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273 · MNH
Orthopedic · 27d
Cleared Jul 18, 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · MQP
Orthopedic · 229d
Cleared Aug 16, 2000
SURGICAL DYNAMICS SPINAL RETRACTOR
K002008 · HRX
Orthopedic · 44d
Cleared Mar 10, 2000
SPIRAL RADIUS RODDING SYSTEM
K000009 · KWQ
Orthopedic · 67d
Cleared Oct 27, 1999
NEXT GENERATION RODDING SYSTEM
K992784 · KWQ
Orthopedic · 69d
Cleared Dec 30, 1998
ANTERIOR CERVICAL PLATING SYSTEM
K984342 · KWQ
Orthopedic · 26d
Cleared Dec 22, 1998
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
K983899 · KWQ
Orthopedic · 49d
Cleared Dec 22, 1998
ROGOZINSKI SPINAL ROD SYSTEM
K983904 · KWP
Orthopedic · 49d
Cleared Oct 26, 1998
SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM...
K983197 · KWP
Orthopedic · 45d
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All218 General & Plastic Surgery 146 Orthopedic 24 Obstetrics & Gynecology 13 Neurology 9 General Hospital 8 Gastroenterology & Urology 8 Ear, Nose, Throat 5 Cardiovascular 4 Hematology 1