US FDA approves standalone use of Cavux Cervical Cage-L, Ally Facet Screws

Providence Medical Technology Inc. has received 510(k) clearances from the U.S. Food and Drug Administration (FDA) for standalone use of the Cavux Cervical Cage-L System and Ally Facet Screws.

Manufactured from medical-grade titanium and available in a variety of sizes, the Cavux Cervical Cage-L System implant offers proprietary grit-blasted and acid-etched surfaces; a large space for allogenic, autogenous bone graft; and includes self-drilling, self-tapping screws for additional, standalone fixation.

Ally Facet Screws provide temporary stabilization as an adjunct to spinal fusion. The titanium implants are available in a variety of sizes to accommodate patient anatomy and are intended to provide mechanical support and stability until spinal fusion is achieved. www.providencemt.com

ISO 13485:2016 certification for Product Creation Studio

Product Creation Studio adopted ISO 13485:2016 certification to underscore the company’s commitment to continuous improvement and excellence in product development for the healthcare industry. Following extensive assessment performed by BSI Group, certification confirms that Product Creation Studio’s quality management system has been effectively implemented to the requirements of ISO 13485. The latest update to the standard was released in 2016 and is intended for use by companies involved with the design and production of medical devices.

ISO standards ensure that products are safe, reliable, and of good quality. An ISO quality system provides the highest standard of design by assuring every aspect of product design is addressed. International standards represent a consensus on organizational quality. The FDA, EU, and Health Canada all recognize the ISO 13485:2016 standard as a preferred means to meet their requirements for quality management of medical device development. www.productcreationstudio.com

Cervical interbody implant system approved

NuVasive Inc. officials announce U.S. Food and Drug Administration (FDA) 510(k) clearance of the CoRoent Small Interbody System, indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine, marking the first U.S. clearance for a cervical cage to be used at up to four contiguous levels.

The NuVasive CoRoent Small Interbody System, an interbody cage manufactured from PEEK-Optima, provides stabilization of the spinal motion segment while fusion takes place. A hollow core allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device grip the adjacent vertebrae to resist migration and expulsion of the device. The device includes titanium alloy or tantalum marker pins.

Implants included in the CoRoent Small Interbody System clearance are CoRoent Small (S), CoRoent Small Lordotic (SL), CoRoent Small Lordotic Plus (SLP), CoRoent Small Hyperlordotic (SHL), and CoRoent Small Contoured (SC). www.nuvasive.com