Cervical Interbody Fusion Cage System - India CDSCO Medical Device Registration

Cervical Interbody Fusion Cage System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000363_19a7743fa88cc346f86767d3f2113cc3_a998758410b75c130e5fa58b2f2fb952. 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

Cervical Interbody Fusion Cage System

UID: IMP/MD/2018/000363_19a7743fa88cc346f86767d3f2113cc3_a998758410b75c130e5fa58b2f2fb952

Brand Name

LnK, PathLoc-L

License Holder

L&K Biomed India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

LnK/CastleLoc‐C Cervical Interbody Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (LnK, PathLoc-L) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as disogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LnK/CastleLoc‐C Cervical Interbody Fusion Cage System is used to facilitate Interbody Fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LnK/CastleLoc‐C Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (LnK, PathLoc-L) weeks of non‐operative treatment prior to treatment with an intervertebral cage