SUTURE ANCHOR - India CDSCO Medical Device Registration

SUTURE ANCHOR is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000479_badec14985f61a91f1e8bc3473ec9cde_e10e8ad721b45a57f3f47f4ec84dee8b. This device is marketed under the brand name TWINFIX ULTRA Ti. The license holder is Smith & Nephew Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

SUTURE ANCHOR

UID: IMP/MD/2019/000479_badec14985f61a91f1e8bc3473ec9cde_e10e8ad721b45a57f3f47f4ec84dee8b

Brand Name

TWINFIX ULTRA Ti

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

Intended for use only for the reattachment of soft tissue to bone for the following indications: 1. Shoulder • Rotator cuff tear repairs • Biceps tenodesis • Deltoid repairs 2. Foot and Ankle • Hallux valgus repairs • Medial or lateral instability repairs/reconstructions • Achilles tendon repairs/reconstructions • Midfoot reconstructions • Metatarsal ligament/tendon repairs/reconstructions 3. Elbow • Ulnar or radial collateral ligament reconstructions • Lateral epicondylitis repair • Biceps tendon reattachment

Class C

Screws

Class C

Moisture Responsive Catheter Dressing

Brand: IV3000

Class B

Transparent dressing

Brand: IV3000

Class B