ADJUSTABLE LOOP BUTTON - India CDSCO Medical Device Registration
ADJUSTABLE LOOP BUTTON is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000127_5fefae115e52058ee2fb41736f405585_b42e1bf11dd662908c8dc892a7230a96. This device is marketed under the brand name Infinity Fixation System. The license holder is M/s Linvatec India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Infinity Fixation System
License Holder
M/s Linvatec India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The GraftMax Button ALB and GraftMax Button BTB are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts or bone tendon grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracovascular ligament disruptions. The GraftMax Button Cradle must be used with the GraftMax Button ALB, GraftMax Button BTB or XO Button implants and is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts or bone tendon grafts. Examples of such procedures include anterior cruciated ligament, posterior cruciated ligament, medial collateral ligament, lateral collateral ligment, distal biceps tendon rupture, and separations due to coracoovascular ligament disruptions
MENISCAL REPAIR DEVICE
Brand: Infinity Fixation System
M/s Linvatec India Private Limited
Suspensory Fixation Device
Brand: Infinity Fixation System
M/s Linvatec India Private Limited
PEEK ANCHOR
Brand: Infinity Fixation System
M/s Linvatec India Private Limited
BIOCOMPOSITE ANCHOR FOR INSTABILITY
Brand: Infinity Fixation System
M/s Linvatec India Private Limited
BIOCOMPOSITE ANCHOR FOR RC
Brand: Infinity Fixation System
M/s Linvatec India Private Limited
FIXATION SYSTEM
Brand: Infinity Fixation System
M/s Linvatec India Private Limited
Tenodesis Anchors
Brand: Infinity Fixation System
M/s Linvatec India Private Limited
All suture anchor system
Brand: Infinity Fixation System
M/s Linvatec India Private Limited
All Suture Anchor
Brand: Infinity Fixation System
M/s Linvatec India Private Limited
All Suture Anchor
Brand: Infinity Fixation System
M/s Linvatec India Private Limited
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Arthroscopic Shaver System
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