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OQBClass II

Intervertebral Body Graft Containment Device

21 CFR 888.3085 / Orthopedic
FDA source (opens on fda.gov)

OQB is the FDA product code for Intervertebral Body Graft Containment Device, a class II device type, regulated under 21 CFR 888.3085. FDA's definition for this code reads: "An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OQB
Device name
Intervertebral Body Graft Containment Device
FDA definition
An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.
Regulation
21 CFR 888.3085
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
4
Ingested recalls
0

Clearances, product code OQB

By decision year
4 clearances under product code OQB with a decision year between 2020 and 2025, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OQB by decision year
YearClearances
20201
20232
20251

Applicants with the most clearances

Product code OQB
Applicants holding the most 510(k) clearances under product code OQB
ApplicantClearances
Spineology, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code