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_59981bf26239d36880f29b8f3af07aaf. 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_59981bf26239d36880f29b8f3af07aaf

Brand Name

Healix Advance Knotless PEEK Anchor

License Holder

Johnson & Johnson Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The DePuy Mitek GII Anchor (Healix Advance Knotless PEEK Anchor) is intended for fixation of USP size #2 suture to bone for the indications listed below. Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction. Foot: Hallux valgus reconstruction. Wrist: Scapholunate ligament. Hand: Ulnar or lateral collateral ligament 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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Anchor with Suture-"SHOULDER: Biceps Tenodesis, Acromio

Brand: Healix Advance Knotless PEEK Anchor

Johnson & Johnson Private Limited

Anchor with Suture - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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Anchor with Suture-"SHOULDER: Biceps Tenodesis, Acromio

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