OURClass II

Sacroiliac Joint Fixation

21 CFR 888.3040 / Orthopedic

OUR is the FDA product code for Sacroiliac Joint Fixation, a class II device type, regulated under 21 CFR 888.3040. FDA's definition for this code reads: "sacroiliac joint fusion". As of 2026-09-10, FDA records hold 132 510(k) clearances under this code, the most recent dated 2026-08-24, and one recall.

Classification record

Product code: OUR
Device name: Sacroiliac Joint Fixation
FDA definition: sacroiliac joint fusion
Regulation: 21 CFR 888.3040
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 132
Ingested recalls: 1

Clearances, product code OUR

By decision year

132 clearances under product code OUR with a decision year between 2005 and 2026, 2023 the highest year at 20.

Show the numbers

510(k) clearances under FDA product code OUR by decision year
Year	Clearances
2005	1
2008	1
2009	1
2010	1
2011	3
2012	2
2013	4
2014	3
2015	8
2016	6
2017	4
2018	7
2019	7
2020	7
2021	9
2022	14
2023	20
2024	15
2025	14
2026	5

Applicants with the most clearances

Product code OUR

Applicants holding the most 510(k) clearances under product code OUR
Applicant	Clearances
SI-Bone, Inc.	27
Surgentec LLC	7
Zyga Technology, Inc.	6
Life Spine	5
Orthofix SRL	5
L&K Biomed Co.,Ltd.	4
Tenon Medical, Inc.	4
Aegis Spine, Inc.	3
Camber Spine Technologies	3
Cutting Edge Spine	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 141 companies shown, in name order