External ring Fixation System - India CDSCO Medical Device Registration
External ring Fixation System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000639_afa4acc80c504bf55e8621630eb41d50_03687878950643c103cd0a1efef39a75. This device is marketed under the brand name SORATH, SORATH ORTHO. The license holder is SIGMA SURGICAL PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is Gujarat.
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Brand Name
SORATH, SORATH ORTHO
License Holder
SIGMA SURGICAL PRIVATE LIMITEDDevice Class
Approving Authority
Gujarat
Product Information
The Ring Fixation System consists of series of external fixators intended to be used to stabilize bone segment in a broad range of indications,including fractures, joint fusion, bone transport, lengthening & angular corrections. The system includes Half Rings 5/8 Ring, Rings With Curved Extremities, Italian Femoral Arches, Arches With Holes, Threaded Rods, Telescopic Rods, PostMale/ Female, Hinges-Male/ Female/Standard, Long/Short Connection Plates, Connected Plates With Threaded Ends, Twisted/Curved Plates, Bushing Threaded Sockets, Connection Bolts, Nut, Washers, Bolt, Multiple, Wire Fixation Buckle, Blocks for Half Pins, Universal Joint, Rotational and Translational Device, Oblique Support, Set Screw, Foot Rings, Knurling post male. Implants not included
Pusher
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Surgical Mallet
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Depth Gauge
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Alignment Guide
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Reamer & its attachment
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Retractor Holder
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Instrument system for bipolar hip system
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Bone Tap
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Arthroscopic Instruments
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Surgical Probe
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Pusher
Brand: SORATH, SORATH ORTHO
Surgical Mallet
Brand: SORATH, SORATH ORTHO
Depth Gauge
Brand: SORATH, SORATH ORTHO
Alignment Guide
Brand: SORATH, SORATH ORTHO
Reamer & its attachment
Brand: SORATH, SORATH ORTHO
Retractor Holder
Brand: SORATH, SORATH ORTHO
Instrument system for bipolar hip system
Brand: SORATH, SORATH ORTHO
Bone Tap
Brand: SORATH, SORATH ORTHO
Arthroscopic Instruments
Brand: SORATH, SORATH ORTHO
Surgical Probe
Brand: SORATH, SORATH ORTHO