Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Corentec Co., Ltd.
  • Registration Date 2016-03-31
  • Hit 2048

[Company Information]

□ Name : Corentec Co., Ltd.

□ Website Address : www.corentec.com

□ Location

 ○Manufacturing Plant : 12, Yeongsanhong 1-gil, Ipjang-myeon, Sebuk-gu, Cheonan-si,

Chungcheongnam-do, Korea 31056

 ○Seoul Office : 8F, 11F, Chungho Tower, 483, Gangnam-daero, Seocho-gu, Seoul, Korea 06541

 ○Corentec America : 60 Washington Street, Suite 202, Morristown, NJ 07960, USA

 ○EC Representitive : Emergo Europe Molenstraat 15, 2513 BH, The Hague, The Netherlands

□ Contacts Department

○ Contacts : Oversea Sales Team

       TEL。82-2-3445-5492, Fax。82-2-3445-5467

□ Manufacturer Information : Since its foundationin 2000, the company has focused on

R&D investments which enable the company to build world class technology patents and product portfolio along with the state of art manufacturing and quality control systems recognized by the Korean FDA, FDA, and the SGS and resulted in successfully obtaining KGMP, ISO 9001, ISO 13485, CE Mark and the other key certificates. The manufacturing facilities, established in 2005 have three separate production lines for artificial hip joint, knee joint and other orthopedic device lines. The facilities have an eco-friendly purifying system, a clean-room which fulfills the requirements of GMP and other Bio and Pharmaceutical industry standards along with the highest environmental and safety global standards. Our goal is to open up new era for those who need the artificial orthopedic devices not only by providing innovative, quality, and economic advantages of the products but also by inspiring optimal quality of life to the patients.

[Medical device Information]

□ Product 1

○ Name : Bencox® Hip System

- Acetabular System : Bencox® Cup, Bencox® Hybrid Cup, Bencox® Hybrid 7-Hole Cup, Bencox®

            Mirabo cup, Bencox® Bipolar Cup, Bencox® PE Liner, Bencox® Delta Liner

- Femoral Components:Bencox® Stem, BenfixTM Long Stem, Bencox® ID Stem, Bencox® ID Cemented

            Stem, Bencox® M Stem, , Bencox® Metal Head, Bencox® Delta Head

○ Intended use : Bencox Hip System intended for use in total or partial hip arthroplasty in primary or

revision surgery for the following conditions:

a) Non-inflammatory degenerative joint disease, such as avascular necrosis,

osteoarthritis, traumatic arthritis

b) Inflammatory degenerative joint disease, such as rheumatoid arthritis

c) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the

proximal femur with head involvement, unmanageable using other techniques

d) Patients with failed previous surgery where pain, deformity, or dysfunction persists

e) Revision of previously failed hip arthroplasty.

○」Images : Attachment 1

□ Product 2

○ Name : Lospa® Knee System, Lospa® Modular Knee System

○ Intended use : Lospa Knee System & Lospa Modular Knee System intended for use in total or partial knee arthroplasty in primary or revision surgery for the following conditions:

a) Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint

disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis.

b) Post-traumatic loss of knee joint configuration and function.

c) Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned

to adequate function and stability.

○ Images : Attachment 2

.

□ Product 3

○ Name : LOSPA IS Spinal System

- Screw System:Monoaxial Screw, Polyaxial Screw, Accessories

- Cage System:Metal Cage, PEEK Cage

○ Intended use : LOSPA IS Spinal System Instrument consists of manual operational instruments

that are to be used, for example, for the operation and treatment for the spine.

○ Images : Attachment 3

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Written by 방수영