Posterior Cervical Fixation System - India CDSCO Medical Device Registration

Posterior Cervical Fixation System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000363_c3b839d2afa1f49a77196d21b30b0582_63f40b39e5d98c059b504c94d837a3c1. 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

Posterior Cervical Fixation System

UID: IMP/MD/2018/000363_c3b839d2afa1f49a77196d21b30b0582_63f40b39e5d98c059b504c94d837a3c1

Brand Name

LnK, PathLoc-L

License Holder

L&K Biomed India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The LnK/CastleLoc‐S Posterior Cervical Fixation System is indicated for the following:  DDD (LnK, PathLoc-L)  Spondylolisthesis  Spinal stenosis  Fracture/dislocation  Failed previous fusion  Tumors The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (LnK, PathLoc-L) spine