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Anchor with Suture - India CDSCO Medical Device Registration

Anchor with Suture is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000335_ebf5d2138c2100d19465ca5e1245eb84_d7ae589eaa50fee52fa952a46982fa3c. This device is marketed under the brand name Healix Advance Knotless PEEK Anchor. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
Anchor with Suture
UID: IMP/MD/2019/000335_ebf5d2138c2100d19465ca5e1245eb84_d7ae589eaa50fee52fa952a46982fa3c

Brand Name

Healix Advance Knotless PEEK Anchor

Device Class

Class D

Approving Authority

CDSCO

Product Information

The DePuy Mitek BIOKNOTLESS BR Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation, rotator cuff repair, capsule shift/ capsulo-labral reconstruction, biceps tenodesis, and deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction. Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment. Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

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