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BR ANCHOR WITH SUTURE - India CDSCO Medical Device Registration

BR ANCHOR WITH SUTURE is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000003_d20dac58fdd074b21df68e4023fac6c2_6ab5808c565f27f404a431844f8ee00d. This device is marketed under the brand name HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
BR ANCHOR WITH SUTURE
UID: IMP/MD/2019/000003_d20dac58fdd074b21df68e4023fac6c2_6ab5808c565f27f404a431844f8ee00d

Brand Name

HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Healix Advance Anchor is indicated in soft-tissue to bone fixation in association with post-operative immobilization as follows: Shoulder- Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee- Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique, Ligament Repair, Iliotibial Band Tenodesis; Elbow- Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction; Hip- Capsular Repair, Acetabular Labral Repair

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