Knee Replacement System-Tibial Wedge - India CDSCO Medical Device Registration

Knee Replacement System-Tibial Wedge is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000556_9cf27a30e10680f0b6267055464df0ee_849ff737a108d63da5271e6e20904c7a. This device is marketed under the brand name Sigma PS. 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

Knee Replacement System-Tibial Wedge

UID: IMP/MD/2020/000556_9cf27a30e10680f0b6267055464df0ee_849ff737a108d63da5271e6e20904c7a

Brand Name

Sigma PS

License Holder

Johnson & Johnson Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The P.F.C modular plus tibial wedges and P.F.C Sigma femoral augments are indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post- traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention. Choice of specific femoral and tibial components will depend upon whether the posterior cruciate ligament is retained or excised, the extent and nature of anterior/ posterior ans medial/lateral stabilization, the femoral and / or tibial aurmentation required, and the need for enhanced mechanical fixation provided by femoral and tibial stems or fluted rods. Components are indicated for use only with poymethylmethacrylate(Sigma PS) bone cement. The P.F.C tibial wedge is indicated to provide augmentation of tibial plateau with bony defects

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Knee Replacement System-Femoral

Brand: Sigma PS

Johnson & Johnson Private Limited

Knee Replacement System-Tibial Wedge - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Knee Replacement System-Femoral

Knee Replacement System-Femoral

Knee Replacement System-Tibial Component

Knee Replacement System-Rod

Knee Replacement System-Stem

Knee Replacement System-Tibial tray

Knee Replacement System-Tibial Tray

Knee Replacement System-Tibial Tray

Knee Replacement System-Femoral Stem Bolt

Knee Replacement System-Femoral Stem

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Coronary Artery Bypass Graft

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NON ABSORBABLE SURGICAL SUTURE U. S. P.

NON ABSORBABLE SURGICAL SUTURE U. S. P.

NON ABSORBABLE SURGICAL SUTURE U. S. P.

ABHY-ADV KIT

Hernia Kit