MIS spinal fixation system - India CDSCO Medical Device Registration

MIS spinal fixation system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000363_99c13eaf772f5f241ce03bc8b92d7e65_cfbe007053c8ae78c56190d6934e2eee. 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

MIS spinal fixation system

UID: IMP/MD/2018/000363_99c13eaf772f5f241ce03bc8b92d7e65_cfbe007053c8ae78c56190d6934e2eee

Brand Name

LnK, PathLoc-L

License Holder

L&K Biomed India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

LnK/ PathLoc‐L MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. LnK MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. LnK/ PathLoc‐L MIS Spinal System is intended for non‐cervical pedicle fixation and non‐pedicle fixation for the following indications: degenerative disc disease (LnK, PathLoc-L); spondylolisthesis; trauma (LnK, PathLoc-L); spinal stenosis; curvatures (LnK, PathLoc-L); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a percutaneous approach with MIS Instrumentation, the LnK/ PathLoc‐L MIS Spinal System are intended for non‐cervical pedicle fixation and non‐pedicle fixation for the following indications: degenerative disc disease (LnK, PathLoc-L); spondylolisthesis; trauma (LnK, PathLoc-L); spinal stenosis; curvatures (LnK, PathLoc-L); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients