Disc-O-Tech Medical Technologies, Ltd. - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
16 devices
Cleared
Dec 21, 2007
MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
Orthopedic
219d
Cleared
Dec 17, 2007
METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS
Orthopedic
181d
Cleared
Nov 03, 2006
CONFIDENCE FENESTRATED INTRODUCER NEEDLE
Orthopedic
28d
Cleared
Sep 14, 2006
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
Orthopedic
27d
Cleared
Jun 21, 2006
CONFIDENCE HIGH VISCOSITY BONE CEMENT
Orthopedic
135d
Cleared
Jun 17, 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
Orthopedic
101d
Cleared
May 12, 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
Orthopedic
30d
Cleared
Mar 26, 2004
FIXION HIP SYSTEM
Orthopedic
205d
Cleared
Jan 28, 2004
SKY BONE EXPANDER SYSTEM
Orthopedic
30d
Cleared
Dec 17, 2003
B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
Orthopedic
140d
Cleared
May 30, 2003
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
Orthopedic
63d
Cleared
Mar 08, 2002
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
Orthopedic
88d
Cleared
Dec 19, 2001
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
Orthopedic
63d
Cleared
Jun 19, 2001
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B
Orthopedic
85d
Cleared
Jun 19, 2001
FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM
Orthopedic
78d
Cleared
Jun 06, 2001
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
Orthopedic
30d