FDA-recognized standard · Orthopedic
ISO 23089-2: Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
Yes. FDA recognizes ISO 23089-2 First edition 2021-05 as recognition 11-390, entered 2021-12-20.
Recognized editions of ISO 23089-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-390 | ISO 23089-2 First edition 2021-05 | 2021-12-20 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 23089-2: 21 CFR 888.3080.
Product codes that cite ISO 23089-2
5 FDA product codes cite ISO 23089-2, including MAX, ODP, OVD, OVE, PHM.
- MAX Intervertebral Fusion Device With Bone Graft, Lumbar
- ODP Intervertebral Fusion Device With Bone Graft, Cervical
- OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
- OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
- PHM
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.