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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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CDSCO Registered
Class Class C
Lumber Interbody Fusion Cage System
UID: IMP/MD/2018/000363_562373d106a96512b1fe6bc88ae59e8a_1c2e4479d9408dc4768613e14949f73d

Brand Name

LnK, PathLoc-L

Device Class

Class C

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 L2โ€S1. 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 nonโ€operative treatment prior to treatment with an intervertebral cage

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