Adjustable Loop & Fixed LOOP Button - India CDSCO Medical Device Registration
Adjustable Loop & Fixed LOOP Button is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000542_39f159e100f2b6acef91609227e82dd0_f27748fb2147a5113de8b4d1d49259b3. This device is marketed under the brand name Bone. The license holder is Healyx Enterprises Private. Limited., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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Brand Name
Bone
License Holder
Healyx Enterprises Private. Limited.Device Class
Approving Authority
Central Drug Standards Control Organization, West Zone
Product Information
Healyx Adjustable Loop (Bone) & Fixed Loop Button. are intended to be used as innovative device which eliminates the need to retrieve shortening strands from the joint and allows the surgeons to pull in line with graft advancement. This tight loop implant also facilitate Tibial fixation for all inside reconstruction. A single hamstring Tendon Looped between 2 ACL(Bone), Implants allows for simplified graft passing and tensioning from the femoral and Tibial side in any degree of flexion
