Biorc Anchor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K990770 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Linvatec Corp. →

• What is the primary function of the Biorc Anchor?

  The Biorc Anchor is an orthopedic device designed to provide secure bone fixation. It functions as an absorbable suture anchor intended for use during surgical procedures to ensure reliable attachment.

• What is the regulatory status of this device?

  The Biorc Anchor has received FDA 510(k) clearance under the submission number K990770. It is classified under product code HWC and was determined to be substantially equivalent to existing devices by the orthopedic advisory committee.

• Who is the manufacturer of the Biorc Anchor?

  The Biorc Anchor is manufactured by Linvatec Corp., located in Largo, Florida. They are the applicant responsible for the device's 510(k) clearance.