Globus Medical Independence Spacers

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

GLOBUS MEDICAL SINGAPORE PTE. LTD.

Class:

Class C medical device

Manufactured by:

GLOBUS MEDICAL INC

Therapeutic area:

Orthopaedics

Therapeutic indications:

The INDEPENDENCE Spacers (INDEPENDENCE, INDEPENDENCE TPS, INDEPENDENCE MIS) are stand-alone interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or more contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The INDEPENDENCE Spacers are to be filled with bone graft material, and are to be used with three titanium alloy screws, which accompany the implant. INDEPENDENCE MIS Spacers are to be used with screws and/or anchors. When used without screws or anchors, INDEPENDENCE Spacers may be used as anterior lumbar interbody fusion devices; supplemental fixation is recommended.

Product summary:

Device System Info:[Sterile Medical Device], Sterile implants are sterilized by gamma radiation.; Models: Bone Screw, Fixed Angle 5.5mm, 20mm - 176.120, Bone Screw, Fixed Angle 5.5mm, 22.5mm - 176.122, Bone Screw, Fixed Angle 5.5mm, 25mm - 176.125, Bone Screw, Fixed Angle 5.5mm, 27.5mm - 176.127, Bone Screw, Fixed Angle 5.5mm, 30mm - 176.130, Bone Screw, Fixed Angle 5.5mm, 35mm - 176.135, Bone Screw, Fixed Angle 5.5mm, 40mm - 176.140, Bone Screw, Fixed Angle 5.5mm, 45mm - 176.145, Bone Screw, Fixed Angle 5.5mm, 50mm - 176.150, Bone Screw, Fixed Angle 5.5mm, 55mm - 176.155, Bone Screw, Fixed Angle 5.5mm, 60mm - 176.160, Bone Screw, Variable Angle 5.5mm, 20mm - 176.220, Bone Screw, Variable Angle 5.5mm, 25mm - 176.225, Bone Screw, Variable Angle 5.5mm, 27.5mm - 176.227, Bone Screw, Variable Angle 5.5mm, 30mm - 176.230, Bone Screw, Variable Angle 5.5mm, 35mm - 176.235, Bone Screw, Variable Angle 5.5mm, 40mm - 176.240, Bone Screw, Variable Angle 5.5mm, 45mm - 176.245, Bone Screw, Variable Angle 5.5mm, 50mm - 176.250, Bone Screw, Variable Angle, 5.5mm, 55mm - 176.255, Bone Screw, Variable Angle, 5.5mm, 60mm - 176.260, Self-Drilling Screw, Fixed Angle 5.5mm, 25mm - 176.625, Self-Drilling Screw, Fixed Angle 5.5mm, 27.5mm - 176.627, Self-Drilling Screw, Fixed Angle 5.5mm, 30mm - 176.630, Self-Drilling Screw, Fixed Angle 5.5mm, 35mm - 176.635, Self-Drilling Screw, Fixed Angle 5.5mm, 40mm - 176.640, Self-Drilling Screw, Fixed Angle 5.5mm, 45mm - 176.645, Self-Drilling Screw, Fixed Angle 5.5mm, 50mm - 176.650, Self-Drilling Screw, Fixed Angle 5.5mm, 55mm - 176.655, Self-Drilling Screw, Fixed Angle 5.5mm, 60mm - 176.660, Self-Drilling Screw, Variable Angle 5.5mm, 25mm - 176.725, Self-Drilling Screw, Variable Angle 5.5mm, 27.5mm - 176.727, Self-Drilling Screw, Variable Angle 5.5mm, 30mm - 176.730, Self-Drilling Screw, Variable Angle 5.5mm, 35mm - 176.735, Self-Drilling Screw, Variable Angle 5.5mm, 40mm - 176.740, Self-Drilling Screw, Variable Angle 5.5mm, 45mm - 176.745, Self-Drilling Screw, Variable Angle 5.5mm, 50mm - 176.750, Self-Drilling Screw, Variable Angle 5.5mm, 55mm - 176.755, Self-Drilling Screw, Variable Angle 5.5mm, 60mm - 176.760, INDEPENDENCE Spacer, Small, 8°, 11mm - 376.111, INDEPENDENCE Spacer, Small, 8°, 13mm - 376.113, INDEPENDENCE Spacer, Small, 8°, 15mm - 376.115, INDEPENDENCE Spacer, Small, 8°, 17mm - 376.117, INDEPENDENCE Spacer, Small, 15°, 11mm - 376.211, INDEPENDENCE Spacer, Small, 15°, 13mm - 376.213, INDEPENDENCE Spacer, Small, 15°, 15mm - 376.215, INDEPENDENCE Spacer, Small, 15°, 17mm - 376.217, INDEPENDENCE Spacer, Small, 20°, 13mm - 376.233, INDEPENDENCE Spacer, Small, 20°, 15mm - 376.235, INDEPENDENCE Spacer, Small, 20°, 17mm - 376.237, INDEPENDENCE Spacer, Medium, 8°, 11mm - 376.411, INDEPENDENCE Spacer, Medium, 8°, 13mm - 376.413, INDEPENDENCE Spacer, Medium, 8°, 15mm - 376.415, INDEPENDENCE Spacer, Medium, 8°, 17mm - 376.417, INDEPENDENCE Spacer, Medium, 8°, 19mm - 376.419, INDEPENDENCE Spacer, Medium, 8°, 21mm - 376.421, INDEPENDENCE Spacer, Medium, 15°, 11mm - 376.511, INDEPENDENCE Spacer, Medium, 15°, 13mm - 376.513, INDEPENDENCE Spacer, Medium, 15°, 15mm - 376.515, INDEPENDENCE Spacer, Medium, 15°, 17mm - 376.517, INDEPENDENCE Spacer, Medium, 15°, 19mm - 376.519, INDEPENDENCE Spacer, Medium, 15°, 21mm - 376.521, INDEPENDENCE Spacer, Medium, 20°, 13mm - 376.533, INDEPENDENCE Spacer, Medium, 20°, 15mm - 376.535, INDEPENDENCE Spacer, Medium, 20°, 17mm - 376.537, INDEPENDENCE Spacer, Medium, 20°, 19mm - 376.539, INDEPENDENCE Spacer, Medium, 20°, 21mm - 376.541, INDEPENDENCE Spacer, 29x34, 8°, 11mm - 376.611, INDEPENDENCE Spacer, 29x34, 8°, 13mm - 376.613, INDEPENDENCE Spacer, 29x34, 8°, 15mm - 376.615, INDEPENDENCE Spacer, 29x34, 8°, 17mm - 376.617, INDEPENDENCE Spacer, 29x34, 8°, 19mm - 376.619, INDEPENDENCE Spacer, 29x34, 8°, 21mm - 376.621, INDEPENDENCE Spacer, 29x34, 15°, 13mm - 376.633, INDEPENDENCE Spacer, 29x34, 15°, 15mm - 376.635, INDEPENDENCE Spacer, 29x34, 15°, 17mm - 376.637, INDEPENDENCE Spacer, 29x34, 15°, 19mm - 376.639, INDEPENDENCE Spacer, 29x34, 15°, 21mm - 376.641, INDEPENDENCE Spacer, Large, 8°, 11mm - 376.711, INDEPENDENCE Spacer, Large, 8°, 13mm - 376.713, INDEPENDENCE Spacer, Large, 8°, 15mm - 376.715, INDEPENDENCE Spacer, Large, 8°, 17mm - 376.717, INDEPENDENCE Spacer, Large, 8°, 19mm - 376.719, INDEPENDENCE Spacer, Large, 8°, 21mm - 376.721, INDEPENDENCE Spacer, Large, 15°, 13mm - 376.813, INDEPENDENCE Spacer, Large, 15°, 15mm - 376.815, INDEPENDENCE Spacer, Large, 15°, 17mm - 376.817, INDEPENDENCE Spacer, Large, 15°, 19mm - 376.819, INDEPENDENCE Spacer, Large, 15°, 21mm - 376.821, INDEPENDENCE Spacer, Large, 20°, 15mm - 376.835, INDEPENDENCE Spacer, Large, 20°, 17mm - 376.837, INDEPENDENCE Spacer, Large, 20°, 19mm - 376.839, INDEPENDENCE Spacer, Large, 20°, 21mm - 376.841, Lumbar Anchor, 20mm - 1135.0020, Lumbar Anchor, 25mm - 1135.0025, Lumbar Anchor, 27mm - 1135.0027, Lumbar Anchor, 30mm - 1135.0030, INDEPENDENCE MIS 24 x 30mm 8°, 11mm - 3135.0111, INDEPENDENCE MIS 24 x 30mm 8°, 13mm - 3135.0113, INDEPENDENCE MIS 24 x 30mm 8°, 15mm - 3135.0115, INDEPENDENCE MIS 24 x 30mm 8°, 17mm - 3135.0117, INDEPENDENCE MIS 24 x 30mm 15°, 11mm - 3135.0211, INDEPENDENCE MIS 24 x 30mm 15°, 13mm - 3135.0213, INDEPENDENCE MIS 24 x 30mm 15°, 15mm - 3135.0215, INDEPENDENCE MIS 24 x 30mm 15°, 17mm - 3135.0217, INDEPENDENCE MIS SPACER 24 x 30mm 20°, 13mm - 3135.0313, INDEPENDENCE MIS SPACER 24 x 30mm 20°, 15mm - 3135.0315, INDEPENDENCE MIS SPACER 24 x 30mm 20°, 17mm - 3135.0317, INDEPENDENCE MIS SPACER, 24 x 30mm 25°, 13mm - 3135.0413, INDEPENDENCE MIS SPACER, 24 x 30mm 25°, 15mm - 3135.0415, INDEPENDENCE MIS SPACER, 24 x 30mm 25°, 17mm - 3135.0417, INDEPENDENCE MIS SPACER, 24 x 30mm 25°, 19mm - 3135.0419, INDEPENDENCE MIS SPACER, 24 x 30mm 25°, 21mm - 3135.0421, INDEPENDENCE MIS SPACER, 24 x 30mm 30°, 15mm - 3135.0515, INDEPENDENCE MIS SPACER, 24 x 30mm 30°, 17mm - 3135.0517, INDEPENDENCE MIS SPACER, 24 x 30mm 30°, 19mm - 3135.0519, INDEPENDENCE MIS SPACER, 24 x 30mm 30°, 21mm - 3135.0521, INDEPENDENCE MIS SPACER, 24 x 30mm 30°, 23mm - 3135.0523, INDEPENDENCE MIS SPACER, 24 x 30mm 30°, 25mm - 3135.0525, INDEPENDENCE MIS 26 x 34mm 8°, 11mm - 3135.0611, INDEPENDENCE MIS 26 x 34mm 8°, 13mm - 3135.0613, INDEPENDENCE MIS 26 x 34mm 8°, 15mm - 3135.0615, INDEPENDENCE MIS 26 x 34mm 8°, 17mm - 3135.0617, INDEPENDENCE MIS 26 x 34mm 8°, 19mm - 3135.0619, INDEPENDENCE MIS 26 x 34mm 8°, 21mm - 3135.0621, INDEPENDENCE MIS 26 x 34mm 15°, 11mm - 3135.0711, INDEPENDENCE MIS 26 x 34mm 15°, 13mm - 3135.0713, INDEPENDENCE MIS 26 x 34mm 15°, 15mm - 3135.0715, INDEPENDENCE MIS 26 x 34mm 15°, 17mm - 3135.0717, INDEPENDENCE MIS 26 x 34mm 15°, 19mm - 3135.0719, INDEPENDENCE MIS 26 x 34mm 15°, 21mm - 3135.0721, INDEPENDENCE MIS SPACER 26 x 34mm 20°, 13mm - 3135.0813, INDEPENDENCE MIS SPACER 26 x 34mm 20°, 20mm - 3135.0815, INDEPENDENCE MIS SPACER 26 x 34mm 20°, 17mm - 3135.0817, INDEPENDENCE MIS SPACER 26 x 34mm 20°, 19mm - 3135.0819, INDEPENDENCE MIS SPACER 26 x 34mm 20°, 21mm - 3135.0821, INDEPENDENCE MIS SPACER, 26 x 34mm 25°, 15mm - 3135.0915, INDEPENDENCE MIS SPACER, 26 x 34mm 25°, 17mm - 3135.0917, INDEPENDENCE MIS SPACER, 26 x 34mm 25°, 19mm - 3135.0919, INDEPENDENCE MIS SPACER, 26 x 34mm 25°, 21mm - 3135.0921, INDEPENDENCE MIS SPACER, 26 x 34mm 30°, 17mm - 3135.1017, INDEPENDENCE MIS SPACER, 26 x 34mm 30°, 19mm - 3135.1019, INDEPENDENCE MIS SPACER, 26 x 34mm 30°, 21mm - 3135.1021, INDEPENDENCE MIS SPACER, 26 x 34mm 30°, 23mm - 3135.1023, INDEPENDENCE MIS SPACER, 26 x 34mm 30°, 25mm - 3135.1025, INDEPENDENCE MIS 29mm X 39mm 8°, 11mm - 3135.1111, INDEPENDENCE MIS 29mm X 39mm 8°, 13mm - 3135.1113, INDEPENDENCE MIS 29mm X 39mm 8°, 15mm - 3135.1115, INDEPENDENCE MIS 29mm X 39mm 8°, 17mm - 3135.1117, INDEPENDENCE MIS 29mm X 39mm 8°, 19mm - 3135.1119, INDEPENDENCE MIS 29mm X 39mm 8°, 21mm - 3135.1121, INDEPENDENCE MIS 29mm X 39mm 15°, 13mm - 3135.1213, INDEPENDENCE MIS 29mm X 39mm 15°, 15mm - 3135.1215, INDEPENDENCE MIS 29mm X 39mm 15°, 17mm - 3135.1217, INDEPENDENCE MIS 29mm X 39mm 15°, 19mm - 3135.1219, INDEPENDENCE MIS 29mm X 39mm 15°, 21mm - 3135.1221, INDEPENDENCE MIS S

Authorization date:

2020-03-25