Navigation Links
OXPEKK-IG Device Viking Gains Regulatory Approval in Korea
Date:7/8/2010

KFDA Acceptance of OXPEKK-IG Implantable Polymer

(PRWEB) July 8, 2010 -- Oxford Performance Materials (OPM) is very pleased to announce that the firm’s OXPEKK-IG long-term implantable polymer has been accepted by the Korean Food and Drug Administration (KFDA). The KFDA approved the Viking interspinous spinal device made by OPM’s customer Sintea Plustek.

Acceptance by the KFDA effectively opens the Korean market for Sintea Plustek and is at the same time a major milestone for OPM. “Gaining regulatory approval for our products requires long-term commitment and focus,” said Scott DeFelice, President and CEO of OPM. “With broad acceptance of OXPEKK-IG in Europe and South America, we are delighted that our Asian strategy is now moving to a commercial phase.” OPM has numerous maturing developments in the Korean market and this approval is expected to have near-term commercial impact.

The Viking device produced by Sintea Plustek is, according to excellent reviews from leading surgeons at the Hesperia Hospital and the S. C. Ortopedia and Traumatologia in Milan, a sophisticated device with a brilliant design and optimal biochemical and biomechanical features. “Sintea has been a customer of OPM for more than four years and we find their products, organization and business approach to be very desirable,” said Franco Ronchi, Technical Manager at Sintea Plustek. “We are of course very pleased that we can now expand the markets available to us and look forward to further cooperation with OPM, which we feel enables efficient technical and commercial expansion.”

OPM’s OXPEKK-IG product is a high-performance, ultra-pure thermoplastic with properties very similar to bone. The product is polyetherketoneketone (PEKK) and is within the class of Polyaryletherketone polymers (PAEK). OXPEKK-IG has been extensively implanted worldwide. The product is supported by comprehensive ISO 10993 biocompatibility and purity data. The biocompatibility data is available directly from OPM or in the firm’s extensive FDA masterfile, without any access fees. Given the long implantation history of OXPEKK-IG products, there are now numerous clinically relevant studies available for reference.

About Sintea Plustek
Sintea Plustek was created through the merger of Sintea Biotech SPA and Plustek SRL with the purpose to improve one’s quality of life and longevity by offering innovative systems. Sintea Plustek’s products are ergonomic through minimally invasive surgical techniques, which allow a fast recovery through a lasting safe product. Through its wide range of increasingly advanced products, Sintea Plustek will fulfill each surgeon’s requirements, facilitating an ergonomic design of implants and user-friendly devices. Moreover, it is important to Sintea Plustek to support the supply of innovative systems with additional services. Sintea Plustek plays an important role in the orthopaedic market.
For additional information, please visit www.sinteaplustek.com.

About OPM
Founded in March 2000, OPM has rapidly become an industry leader in the ultra-high performance thermoplastic polymers market. The firm’s versatile OXPEKK polymers are currently being used in medical, space and defense, semiconductor and industrial markets worldwide. OPM is ISO 9001:2000 and ISO 13485:2003 certified.
In February 2009 OPM was acquired by France’s leading chemicals producer, Arkema.
For additional information, please visit www.oxfordpm.com or www.arkema.com/opm.

About Arkema
A global chemical company and France’s leading chemicals producer, Arkema consists of three strategically related businesses: Vinyl Products, Industrial Chemicals, and Performance Products. Arkema reported sales of 5.6 billion euros in 2008. Arkema has 15,000 employees across 40 countries and six research centers located in France, the United States and Japan. With internationally recognized brands, Arkema holds leadership positions in its principal markets.
For additional information, please visit www.arkema.com

OXPEKK is a registered trademark of Oxford Performance Materials, Inc.

Read the full story at http://www.prweb.com/releases/OXPEKK-IG/KFDA_Clearance/prweb4229774.htm.


'/>"/>
Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved  

Related biology technology :

1. Texas Tech, U of Utah win Sandia microdevice competition
2. Diabetes Care Devices Market In Brazil, Russia, India, China (BRIC) Worth $570.56 Million In 2014
3. Medical Device Manufacturer MRPC Drives Quality With ‘Scientific Molding'
4. Ben-Gurion University students develop device to help blind manuever
5. CORDIS Launches ExoSeal(TM) Vascular Closure Device
6. Redsense Medical Receives FDA Clearance for the Redsense Safety Device for Home/Self use During Home Hemodialysis
7. Ultra-Fine Metal Tubing Smoothes the Way for Miniaturized Medical Devices
8. PolyTouch Medical Ltd. Announces the Submission of a Premarket Application for PatchAssist - an Innovative Mesh Deployment and Placement Device for Laparoscopic Hernia Repair
9. InterTech Service to Counter Widely Reported Problems in Automotive, Medical Device and Other Industries Requiring Rigorous Quality Standards
10. Medical Device Designers Avoid the Pitfalls of Outsourcing Medical Tubing
11. Sorting device for analyzing biological reactions puts the power of a lab in a researchers pocket
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
OXPEKK-IG Device Viking Gains Regulatory Approval in Korea
(Date:3/23/2017)... ... ... to announce it has become the premiere team-building cooking event company in San Diego. ... as Illumina, HP and Qualcomm, and is ranked #1 in its category on Trip Advisor. ... new team building format, a way for teams to not only interact with one another ...
(Date:3/23/2017)... MILFORD, Mass. , March 23, 2017 ... leading partner to global in vitro diagnostics ... launch of the industry,s first multiplexed ... inherited disease testing by next-generation sequencing ... materials were developed with input from industry ...
(Date:3/23/2017)... ... March 23, 2017 , ... Ellen Matloff, president and ... Council (CTC) as a 2017 Women of Innovation® finalist. Matloff will be among ... Dinner. , The dinner recognizes women accomplished in science, technology, engineering and math ...
(Date:3/23/2017)... York , March 23, 2017 According ... plasma products and derivatives market is fragmented due to the presence of ... such as Proliant, Thermo Fisher , and Sigma-Aldrich, compete with ... these three companies, collectively, held more than 76% of this market ... As ...
Breaking Biology Technology:
(Date:3/22/2017)... 2017   Neurotechnology , a provider of ... announced the release of the SentiVeillance 6.0 ... facial recognition using up to 10 surveillance, security ... The new version uses deep neural-network-based facial detection ... utilizes a Graphing Processing Unit (GPU) for enhanced ...
(Date:3/20/2017)... At this year,s CeBIT Chancellor Dr. Angela Merkel visited ... to the DERMALOG stand together with the Japanese Prime Minster Shinzo Abe. ... the largest German biometrics company the two government leaders could see the ... well as DERMALOG´s multi-biometrics system.   Continue Reading ... ...
(Date:3/13/2017)... , March 13, 2017 Future of security: Biometric Face ... ... DERMALOGs Face Matching enables to match face pictures against ... basis to identify individuals. (PRNewsFoto/Dermalog Identification Systems) ... DERMALOG,s "Face Matching" is the fastest software for biometric Face Matching ...
Breaking Biology News(10 mins):