OWIClass II

Bone Fixation Cerclage, Sublaminar

21 CFR 888.3010 / Orthopedic

OWI is the FDA product code for Bone Fixation Cerclage, Sublaminar, a class II device type, regulated under 21 CFR 888.3010. FDA's definition for this code reads: "Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion". As of 2026-09-10, FDA records hold 37 510(k) clearances under this code, the most recent dated 2026-05-27, and 2 recalls.

Classification record

Product code: OWI
Device name: Bone Fixation Cerclage, Sublaminar
FDA definition: Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
Regulation: 21 CFR 888.3010
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: 37
Ingested recalls: 2

Clearances, product code OWI

By decision year

37 clearances under product code OWI with a decision year between 2011 and 2026, 2017 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code OWI by decision year
Year	Clearances
2011	1
2013	2
2014	3
2015	3
2016	5
2017	7
2018	4
2019	3
2020	3
2021	1
2022	1
2023	2
2026	2

Applicants with the most clearances

Product code OWI

Applicants holding the most 510(k) clearances under product code OWI
Applicant	Clearances
Implanet	7
Medicrea International	5
Globus Medical, Inc.	3
K2M, Inc	3
Cousin Biotech SAS	2
Nu Vasive, Incorporated	2
Orthopediatrics Corp	2
Spinal Elements, Inc	2
Zimmer Spine, Inc.	2
Alphatec Spine, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 59 companies shown, in name order