Revision Knee Components - India CDSCO Medical Device Registration

Revision Knee Components is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000702_f54a59945381c40b0ba68d90ba0651a8_5ee36f13a948ba01f949d12068d94dd4. This device is marketed under the brand name Stemmed Tibial Components & PCK Components. The license holder is M/s ELECTRO MAGNETIC INDUSTRIES, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class C

Revision Knee Components

UID: MFG/MD/2023/000702_f54a59945381c40b0ba68d90ba0651a8_5ee36f13a948ba01f949d12068d94dd4

Brand Name

Stemmed Tibial Components & PCK Components

License Holder

M/s ELECTRO MAGNETIC INDUSTRIES

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The Destiknee Stemmed Tibial Components/PCK components are designed to be used with Destiknee-Total Knee System, and is indicated for the following: • Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. •Correction of functional deformities. Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. • Moderate valgus, varus, or flexion trauma. • Knee fractures untreatable by other methods • Revision surgery where sufficient bone stock and soft tissue integrity are present These Components are intended for cemented use only. This device is for single use only

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Intramedullary Nails

Brand: Stemmed Tibial Components & PCK Components

M/s ELECTRO MAGNETIC INDUSTRIES

Class C

Bone Plates

Brand: Stemmed Tibial Components & PCK Components

M/s ELECTRO MAGNETIC INDUSTRIES

Class C

Total Knee system

Brand: Stemmed Tibial Components & PCK Components

M/s ELECTRO MAGNETIC INDUSTRIES

Class C

Bone Screws

Brand: Stemmed Tibial Components & PCK Components

M/s ELECTRO MAGNETIC INDUSTRIES

Class C

Revision Knee Components

Brand: Stemmed Tibial Components & PCK Components

M/s AKSHAR GAMMA STERILES LLP

Class C

Total Knee system

Brand: Stemmed Tibial Components & PCK Components

M/s AKSHAR GAMMA STERILES LLP

Class C

Revision Knee Components

Brand: For Gamma Sterilization

Agrosurg Irradiators (India) Pvt. Ltd.

Class C

Guide Wire

Brand: Stemmed Tibial Components & PCK Components

Meril Healthcare Pvt. Ltd. ,Ground & First Floor, Survey No.173/4 and First Floor, H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi-396191 Gujarat, India. ,Valsad Gujarat ,396191 ,India

Class C

Total Knee system

Brand: Stemmed Tibial Components & PCK Components

Class C

Total Knee system

Brand: Stemmed Tibial Components & PCK Components

Class C

Other Products from M/s ELECTRO MAGNETIC INDUSTRIES

Products from the same license holder (10 products)

Total Hip Replacement System

Brand: For Gamma Sterilization

Class D

Intramedullary Nails

Brand: Stemmed Tibial Components & PCK Components

Class C

Bone Plates

Brand: Stemmed Tibial Components & PCK Components

Class C

Total Knee system

Brand: Stemmed Tibial Components & PCK Components

Class C

Total Hip Replacement System

Brand: For Gamma Sterilization

Class D

Hip Acetabular System

Brand: For Gamma Sterilization

Class D

Bone Screws

Brand: Stemmed Tibial Components & PCK Components

Class C

Oxidized Regenerated Cellulose Haemostat

Brand: SURGISPON®, MEDISPONGE, UNISPONGE, BLOXANG, GEL-SPONGE, HEMOGEL, HEMOSPONGE, PERISPONGE™, SURGIGEL, TOP DENT DENTOSTAN, EVOSPON, CLINIX, HYGITECH, R&S, KENTDENTAL, OCTOCALOGEN, TOPISPON, SURGISENZ, MVG, SCHMIDT, ILION DENTAL, GELASPON, GELASPON KDM, PROCLINIC, BESTDENT, STELLIGEL, BIOSPONGE, FLOSPONG, SMI-SPON, MEDISPON, CLINISPON, I-SPONGE, MERIFEIM, DSI SPONGE, CHIRUSPONGE, MERIFOAM, IDSPONGE, DENTOSPON, KARESPON, HEMOSPON, ALPHA-SPON

Class D

Flowable Gelatin Haemostatic Matrix Kit

Class D

Absorbable Gelatine Sponge

Class D