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Real Intelligence™ Cori™

by Blue Belt Technologies, Inc. 510(k) 3 variants

Active United States Open recall

510(k) K231963

Regulatory status

as of 29 Oct 2026

Recall ongoing. 2 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK231963 Date1 Aug 2023ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0708-2024 FDA Class II initiated 13 Nov 2023

    Possibility that the user is unable to resolve drill disconnection error messages.

    • Ongoing Z-0041-2024 FDA Class II initiated 7 Sep 2023

    CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis

Specification

510(k)

510(k) Number
FDA Product Code
OLO
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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