FDA-recognized standard · Orthopedic
ASTM F3631: Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
Yes. FDA recognizes ASTM F3631-24 as recognition 11-418, entered 2024-12-23.
Recognized editions of ASTM F3631
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-418 | ASTM F3631-24 | 2024-12-23 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F3631: 21 CFR 888.3080.
Product codes that cite ASTM F3631
5 FDA product codes cite ASTM F3631, 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.