Expedium Spine System- Spinal System Rod -Non-Sterile -Titanium - India CDSCO Medical Device Registration

Expedium Spine System- Spinal System Rod -Non-Sterile -Titanium is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000044_dad5486fec89b04cc7a0b8ad8a7b93d3_d1cb945085fb559cb039427c8a3168e2. This device is marketed under the brand name Non-Sterile. The license holder is Johnson & Johnson 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

Expedium Spine System- Spinal System Rod -Non-Sterile -Titanium

UID: IMP/MD/2022/000044_dad5486fec89b04cc7a0b8ad8a7b93d3_d1cb945085fb559cb039427c8a3168e2

Brand Name

Non-Sterile

License Holder

Johnson & Johnson Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The EXPEDIUM and VIPER Spine Systems are 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. The EXPEDIUM and VIPER Spine Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (Non-Sterile); spondylolisthesis; trauma (Non-Sterile); spinal stenosis; curvatures (Non-Sterile); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (Non-Sterile); spondylolisthesis; trauma (Non-Sterile); spinal stenosis; curvatures (Non-Sterile); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM VERSE System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM VERSE systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach

Class C

Spinal System - Monarch - Connector -Non-Sterile - Titanium

Brand: Non-Sterile

Johnson & Johnson Private Limited

Class C

Brand: PROLENE*

Class D