CDSCO UID IMP/MD/2020/000120_40a661f1955e6248860d07d75bfd9c8f_7e9cb9f3fb92549c853e78ba52488227
Cervios ChronOS Prefilled Cages
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·India CDSCO·Brand: plates
Registration details
- UID
- IMP/MD/2020/000120_40a661f1955e6248860d07d75bfd9c8f_7e9cb9f3fb92549c853e78ba52488227
- Device class
- Class D
- Brand name
- plates
- 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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About this record
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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