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Tyber Medical receives 510(k) clearance for interbody systems

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Tyber Medical announced it has received FDA 510(k) clearance for TyPEEK and non-sterile and sterile PEEK interbody implant systems.

TyPEEK is a proprietary titanium plasma sprayed interbody fusion device s used when PEEK alone is not sufficient for the fusion. TyPEEK is designed to offer the benefits of bone-titanium osseointegration with the modulus and postoperative imaging characteristics of PEEK, according to a company press release.

“The FDA clearance is an important milestone for Tyber Medical and a major risk we can remove for our customers,” Jeff Tyber, Chief Executive Officer of Tyber Medical, stated in the press release. “Our comprehensive CE Mark and FDA approved private labeled interbody portfolio includes over 3,000 different product offerings, including the first available titanium plasma sprayed direct lateral lumbar system.”

Both the TyPEEK and PEEK interbody fusion devices include configurations for anterior cervical, anterior lumbar, posterior lumbar, oblique lumbar, transforaminal lumbar and direct lateral interbody fusion spacers.