Cervios ChronOS Prefilled Cages - India CDSCO Medical Device Registration

Cervios ChronOS Prefilled Cages is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000120_40a661f1955e6248860d07d75bfd9c8f_7e9cb9f3fb92549c853e78ba52488227. This device is marketed under the brand name plates. The license holder is Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Cervios ChronOS Prefilled Cages

UID: IMP/MD/2020/000120_40a661f1955e6248860d07d75bfd9c8f_7e9cb9f3fb92549c853e78ba52488227

Brand Name

plates

License Holder

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Device Class

Class D

Approving Authority

CDSCO

Product Information

"chronOS Prefilled Cages are designed for Posterior Lumbar Interbody Fusion (plates) and Anterior Cervical Interbody Fusion (plates). The porous structure of chronOS implants acts as a matrix for the ingrowth of bone. chronOS implants must always be applied by enosseal or subperiosteal implantation, i.e. by direct contact with the vital bone. Anterior Cervical Interbody Fusion: Cervical pathologies where segmental spondylodesis is indicated: –– Ruptured and herniated discs –– Degenerative disc disease and instabilities –– Pseudoarthrosis or failed spondylodesis For multisegmental arthodesis additional fixation with a plate is recommended. Posterior Lumbar Interbody Fusion: Lumbar and lumbosacral pathologies for which segmental spondylodesis is indicated, especially: –– Degenerative disc disease and instability –– Degenerative spondylolisthesis, grade I or II –– Spondylolisthesis with stenosis, grade I or II –– Pseudarthrosis or failed spondylodesis As a rule, chronOS is resorbed within 6 to 18 months and converted into autologous bone; depending on patient conditions."

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RapibSorb Resorbable Fixation System

Brand: plates

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

RapibSorb Resorbable Fixation System

Brand: plates

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

RapibSorb Resorbable Fixation System -"The Synthes resorbable plate, mesh, foil, screw and tack system is used for bone fixation in the management of fractures or reconstructions of the craniofacial skeleton and as graft containment. The plates, meshes, foils, screws and tacks should only be used in locations subject to low biomechanical loading, i.e. non- load-bearing osteosynthesis exclusively. Examples of appropriate indications include: – Trauma repair and reconstructive procedures in the mid facial area, maxilla and cranium. – Containment of bone grafts or bone graft substitutes in other parts of the body in non-load-bearing indications.",chronOS Bone Void Filler Implants

Brand: plates

Johnson & Johnson Private Limited ,A-1/ 50, Room No. 2, 100 Shed Area, G.l.D.C., Vapi, Tal Pardi (Valsad) ,Valsad Gujarat ,396195 ,India

Class D

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