On March 12, the FDA issued a warning letter to NuVasive for selling Affix Spinous Process Plate systems for uses not approved by the device's 510(k) clearance.
Spinal Tech
Princeton, N.J.-based Regentis Biomaterials received European CE Mark approval for the GelrinC biodegradable orthopedic implant.
Zimmer Holdings currently has exposure of 75 percent for hip and knee orthopedic device markets, and the company is looking to grow., according to the Wall Street Transcript.
Stryker has launched its ES2 Spinal System to build on its current Xia 3 pedicle screw.
U.K.-based Invibio now has 500 PEEK-OPTIMA biomaterial devices cleared for commercial use in the U.S. and more than 80 in China.
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San Clemente, Calif.-based VertiFlex plans to sell some of its non-core spine technology to Stryker.
The Food and Drug Administration granted 41 orthopedic- and spine-related device clearances in February.
Stephen Cook, PhD, joined the board of directors of Parsippany, N.J.-based Precision Spine.
Fishers, Ind.-based Nexxt Spine will move its headquarters and manufacturing plan to Noblesville, Ind., according to the Indianapolis Business Journal.
The FDA sent Stryker a warning letter for quality concerns at the device maker's Portage, Mich., facility, according to Medscape Today.