Strategic Orthopaedic-related 510(k) Update
Discover which orthopaedic companies recently received strategic FDA 510(k) clearances to market their products....
Dec 09 2014,
Hip Replacement Companies Expand Portfolios with New Product Launches
FDA Extends UDI Compliance Date for Certain Orthopaedic Implants
A variety of fixation screws, plates and spinal devices will not need to meet UDI labeling requirements until 2016....
Dec 09 2014,
Resonetics Expands to California with New San Diego Facility
The 9,000 square foot facility will offer an array of laser processing technologies, a class 8 clean room and 24/5...
Dec 04 2014,
CoorsTek Medical Acquires European Medical Device Manufacturer Nanosurfaces Industries
NSI was the manufacturing division of SAMO, one of Europe's longest-standing orthopaedic OEMs....
Nov 19 2014,
Oxford Performance Materials Receives NIH Grant to Improve Treatment of Infections Related to Artificial Hips, Knees
The NIH grant will support research developing new approaches for the delivery of antibiotics through OPM's 3D printed PEKK implants....
Nov 19 2014,
Preparation for Spinal Reclassification Under Way, Despite Pending EU Regulations
While the EU has yet to set a completion or implementation date for spine implant reclassification, manufacturers shouldn’t wait to...
Nov 07 2014,
Uncover Opportunities in Your Supply Chain Challenges
Overcome challenges in the orthopaedic device supply chain with these tips on how to leverage new technologies, enter new markets,...
Nov 07 2014,
FDA Focuses on Properties and Biocompatibility of AM Medical Devices
Understand FDA’s current thinking on the regulatory process for additive manufactured devices....
Nov 07 2014,
FDA Surveillance Inspections and Warning Letters Decrease
A CDRH quality system data report offers insight into common observations from 2013. Familiarize yourself with these trends and action...
Nov 07 2014,
FDA Addresses Custom Device Exemptions
FDA clarified changes to the Custom Device Exemption provision through a final guidance document....
Nov 07 2014,
Pro-Dex Launches Engineering Services Division
Pro-Dex launched its Engineering Services Division, a new business line that recruits and places contract personnel and provides engineering and...
Nov 05 2014,
Oberg Costa Rica Receives ISO 13485 Certification
Oberg Costa Rica has achieved ISO 13485:2003 certification from the British Standards Institution....
Nov 05 2014,
Oxford Performance Materials and Yale to Develop 3D Printed Biomedical Technologies
Projects include the development of new PEKK-based cranial and facial devices that support direct tissue attachment and 3D printed PEKK...
Oct 29 2014,
Interstate Plastics Names Mark Courtright President
Courtright succeeds Galen Klokkevold as President of Interstate Plastics, a full-line distributor of plastic sheets, rods, tubes, films, bars and...
Oct 29 2014,
nanoMAG Signs License Agreement to Develop Bioabsorbable High-Strength Magnesium Alloy Implants
The collaboration is focused on achieving certain milestones, including regulatory approval for this new class of materials for use in...
Oct 13 2014,