November 27, 2022
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OsteoCentric Technologies receives FDA clearance for pedicle screw fastener, fusion system
OsteoCentric Technologies has announced FDA 510(k) clearances for its OsteoCentric pedicle screw fastener system and its Integrity-SI spinal fusion system, according to a company press release.
The OsteoCentric pedicle screw fastener system and the Integrity-SI fusion system utilize OsteoCentric’s UnifiMI technology, which creates stability between the pedicle and implant, limits loosening and increases stability, according to the release.
“The UnifiMI pedicle fastener will be the only system on the market leveraging mechanical integration technology to address implant instability at the bone-implant interface,” Eric Brown, founder and CEO of OsteoCentric Technologies, said in the release.
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