Hip System(CoCr - Modular Head) - India CDSCO Medical Device Registration

Hip System(CoCr - Modular Head) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000456_50017046f7b516460f8e70f37f7917ad_720e0a79addce2d380270f0ce09cdf36. This device is marketed under the brand name Vanguard Knee System - tibial Component. The license holder is Zimmer India 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

Hip System(CoCr - Modular Head)

UID: IMP/MD/2019/000456_50017046f7b516460f8e70f37f7917ad_720e0a79addce2d380270f0ce09cdf36

Brand Name

Vanguard Knee System - tibial Component

License Holder

Zimmer India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The Echo Press-Fit Hip System is intended for uncemented use only. Polished Femoral Hip Prosthesis with Proximal Cement Spacer is intended for cemented use only and may be used in partial and total hip arthroplasties. The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies. The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use. Porous coated devices are marketed for non-cemented use in the United States for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease

Class C

Knee System

Brand: Vanguard Knee System - tibial Component

Zimmer India Private Limited

Class C

Brand: Lorenz® Surgical Instruments

Class B