Cleared Special

K222512 - Integrity-SI Fusion System
(FDA 510(k) Clearance)

K222512 · OsteoCentric Technologies · Orthopedic

Sep 2022

Decision

24d

Days

Class 2

Risk

K222512 is an FDA 510(k) clearance for the Integrity-SI Fusion System. This device is classified as a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR).

Submitted by OsteoCentric Technologies (Logan, US). The FDA issued a Cleared decision on September 12, 2022, 24 days after receiving the submission on August 19, 2022.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.

Submission Details

510(k) Number	K222512 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2022
Decision Date	September 12, 2022
Days to Decision	24 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF