Biodegradable Fixation System - India CDSCO Medical Device Registration

Biodegradable Fixation System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000683_be86accec250683fed0d603b953ba5b3_54c734ea81e03974d4d45fbb07c036a2. This device is marketed under the brand name Inion Hexalon™ Biodegradable ACL/PCL Screw. The license holder is Mn Solutions, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Biodegradable Fixation System

UID: IMP/MD/2021/000683_be86accec250683fed0d603b953ba5b3_54c734ea81e03974d4d45fbb07c036a2

Brand Name

Inion Hexalon™ Biodegradable ACL/PCL Screw

License Holder

Mn Solutions

Device Class

Class C

Approving Authority

CDSCO

Product Information

INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid‐face and maxilla. Specific indications: Fractures of the cranium, mid‐face and maxilla, Infant craniofacial surgery (Inion Hexalon™ Biodegradable ACL/PCL Screw), LeFort (Inion Hexalon™ Biodegradable ACL/PCL Screw) osteotomies, Pediatric reconstructive procedures, Orthognathic or reconstructive procedures of the cranium, mid‐face, or maxilla, Craniotomy flap fixation. INION CPS™ 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM is intended for use in the trauma and reconstructive procedures in the craniofacial skeleton, mid‐face and maxilla and mandible (Inion Hexalon™ Biodegradable ACL/PCL Screw). The INION CPS™ Orbital Plates are intended for use in trauma and reconstructive procedures of the orbital cavity as part of the INION CPS™ 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM. Specific indications: Fractures of the cranium, mid‐face, maxilla and mandible, Infant craniofacial surgery (Inion Hexalon™ Biodegradable ACL/PCL Screw), LeFort (Inion Hexalon™ Biodegradable ACL/PCL Screw) osteotomies, Pediatric reconstructive procedures, Orthognathic or reconstructive procedures of the cranium, mid‐face, maxilla or mandible, Craniotomy flap fixation.

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