Aesculap wins 510(k) for spinal fusion device

September 10, 2010 by MassDevice staff

Aesculap Implant Systems LLC wins Food & Drug Administration 510(k) clearance for the S4 cervical occipital plating system.

Aesculap logo

The Food & Drug Administration cleared Aesculap Implant Systems LLC's S4 cervical occipital plating system.

The Center Valley, Pa.-based company received a "substantial equivalence" determination for its Special 510(k) application for the spinal injury treatment system seven months after the FDA began its review of the device, according to the company.

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