ADJUSTABLE LOOP BUTTON
- UID
- IMP/MD/2018/000127_5fefae115e52058ee2fb41736f405585_b42e1bf11dd662908c8dc892a7230a96
- Device class
- Class C
- Brand name
- Infinity Fixation System
- License holder
- M/s Linvatec India Private Limited
- 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
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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