Lumber Interbody Fusion Cage System - India CDSCO Medical Device Registration
Lumber Interbody Fusion Cage System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000363_562373d106a96512b1fe6bc88ae59e8a_1c2e4479d9408dc4768613e14949f73d. This device is marketed under the brand name LnK, PathLoc-L. The license holder is L&K Biomed India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
LnK, PathLoc-L
License Holder
L&K Biomed India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
LnK Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (LnK, PathLoc-L) at one or two contiguous levels from L2โS1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(LnK, PathLoc-L). This device is to be used with autogenous bone graft. LnK Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (LnK, PathLoc-L) months of nonโoperative treatment prior to treatment with an intervertebral cage
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Brand: LnK, PathLoc-L
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Cervical Interbody Fusion Cage System
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