CDSCO UID IMP/MD/2019/000088_82111bdd87df1db151c46ec6062782d5_6e32c695cef96c2dc03eee1fb46d6e1f
Recon and Trauma Cable System
Stryker India Pvt. Ltd.,·Device Class Class C·India CDSCO·Brand: Trident II Acetabular Component System
Registration details
- UID
- IMP/MD/2019/000088_82111bdd87df1db151c46ec6062782d5_6e32c695cef96c2dc03eee1fb46d6e1f
- Device class
- Class C
- Brand name
- Trident II Acetabular Component System
- License holder
- Stryker India Pvt. Ltd.,
- Approving authority
- CDSCO
- Product information
- The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (Trident II Acetabular Component System) approach. The DALL-MILES mini cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment. The mini cleat and tension band implant are intended for use with the DALL-MILES System for trochanteric reattachment only. The DALL-MILES grooved button is intended to be used in conjunction with the HOWMEDICA ALTA Femoral Channel Plate and the DALL-MILES System for femoral fracture fixation. The DALL-MILES cables and cable sleeves are indicated for spinal wiring, trochanteric reattachment and sternotomy applications; trauma surgery of the shoulder, elbow, knee, hip and ankle; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation. The DALL-MILES stainless steel compression plate is indicated for fracture fixation of long bones when screw and plate fixation alone is inadequate due to poor bone quality or when screws cannot be placed because of internal fixation devices. The DALL-MILES trochanteric grips and grip plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device The DALL-MILES trochanteric grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies. The Cerclage wire is indicated for bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures, and bone reconstruction procedures
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About this record
Recon and Trauma Cable System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000088_82111bdd87df1db151c46ec6062782d5_6e32c695cef96c2dc03eee1fb46d6e1f. This device is marketed under the brand name Trident II Acetabular Component System. The license holder is Stryker India Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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