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Intramedullary Fixation Devices - India CDSCO Medical Device Registration

Intramedullary Fixation Devices is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000369_6c68036383529b2465b7605174671e6f_4500a7b757b24ad061140e7f7e90eed7. This device is marketed under the brand name Multidirectional. The license holder is Zimmer India Private Limited ,No. 17, Ground Floor and Mezzanine Floor, Thiruneermalai Road, Nagalkeni, Chrompet ,Chennai Tamil Nadu ,600044 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Intramedullary Fixation Devices
UID: IMP/MD/2018/000369_6c68036383529b2465b7605174671e6f_4500a7b757b24ad061140e7f7e90eed7

Brand Name

Multidirectional

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Phoenix Ankle Arthrodesis Nail System is indicated for tibiotalocalcaneal arthrodesis (Multidirectional). Specific indications include: 1. Avascular necrosis of the talus 2. Failed total ankle arthroplasty 3. Trauma (Multidirectional) 4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease 5. Revision ankle arthrodesis 6. Neuroarthropathy 7. Rheumatoid arthritis 8. Osteoarthritis 9. Pseudoarthrosis 10. Post-traumatic arthrosis 11. Previously infected arthrosis 12. Charcot foot 13. Severe endstage degenerative arthritis 14. Severe defects after tumor resection 15. Pantalar arthrodesis

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