Alphatec Spine Inc.
Division of Alphatec Holdings Inc.
Latest From Alphatec Spine Inc.
'Where Technology Meets Science': Doctors, Medical Students Take Experimental Medtech For A Spin In Pittsburgh's Center For Surgical Arts
Some big-name device-makers – Medtronic, Stryker, Karl Storz, Siemens and more – are donating expensive capital equipment to the Center for Surgical Arts, a modern teaching lab that boasts 21 bays for training residents and fellows in various types of surgery. The companies are doing this to not only nail down future customers, but to test new devices, as well. The Center also includes a Bose test frame that was used to help clear Alphatec Spine's Solus device with US FDA without a clinical trial. "Those can be multimillion-dollar studies. So, to be able to do that, and to have the FDA feel comfortable with that, is kind of a cool capability," says Dr. Donald Whiting, chair of the Allegheny Health Network Neuroscience Institute.
After two deaths and several injuries tied to the use of third-party accessories with the company’s NavLock Tracker surgical assistant, Medtronic has changed its labeling to warn against use of non-Medtronic accessories, but FDA suggests there are also other agency-cleared alternatives.
Recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
Warning Letter: Exoskeleton Firm Dodged Communication With FDA Over Postmarket Study, Failed To Assemble Surveillance Plan
An FDA warning letter sent to Argo Medical Technologies, now named ReWalk Robotics, outlines the company's failure to conduct mandatory postmarket surveillance activities on its ReWalk bionic walking assistance system. The missive to Argo also lays out a timeline of events that describes how the agency chased after the company.
- Implantable Devices
Surgical Equipment & Devices
- Minimally or Less Invasive
- Therapeutic Areas
- Musculoskeletal & Connective Tissue Disorders
- Alphatec Manufacturing Inc.
- North America
- Parent & Subsidiaries
- Alphatec Holdings Inc.
- Senior Management
Jeffrey G Black, EVP, CFO
Kristine M Jacques, VP, Product Mktg.
Daniel J Bernarde, VP, Corp. Dev.
J.P. Timm, VP, R&D
Stephen A Lubischer, VP, Sales
- Contact Info
Alphatec Spine Inc.
Phone: (760) 431-9286
5818 El Camino Real
Carlsbad, CA 92008
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