Cleared Traditional

Curiteva Sacroiliac Joint Fusion System

K210402 · Curiteva, Inc. · Orthopedic
Sep 2021
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K210402 is an FDA 510(k) clearance for the Curiteva Sacroiliac Joint Fusion System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on September 9, 2021, 211 days after receiving the submission on February 10, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K210402 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2021
Decision Date September 09, 2021
Days to Decision 211 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OUR — Sacroiliac Joint Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion

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