Lumber Interbody Fusion Cage System
- UID
- IMP/MD/2018/000363_562373d106a96512b1fe6bc88ae59e8a_1c2e4479d9408dc4768613e14949f73d
- Device class
- Class C
- Brand name
- LnK, PathLoc-L
- License holder
- L&K Biomed India Private Limited
- 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 L2‐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 non‐operative treatment prior to treatment with an intervertebral cage
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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