RapibSorb Resorbable Fixation System - India CDSCO Medical Device Registration

RapibSorb Resorbable Fixation System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000120_ba4ef111d898dac75fc99abcab707a80_d0f3e5ffa4e527c24ee6e1745f6f5017. 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

RapibSorb Resorbable Fixation System

UID: IMP/MD/2020/000120_ba4ef111d898dac75fc99abcab707a80_d0f3e5ffa4e527c24ee6e1745f6f5017

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

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

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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

Cervios ChronOS Prefilled Cages

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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