FDA-recognized standard · Orthopedic
ASTM F2077: Standard Test Methods for Intervertebral Body Fusion Devices
Yes. FDA recognizes ASTM F2077-24 as recognition 11-421, entered 2025-05-26. FDA also lists ASTM F2077-18 (recognition 11-347, transition period ending 2027-07-04).
Recognized editions of ASTM F2077
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-421 | ASTM F2077-24 | 2025-05-26 | Complete | — |
| 11-347 | ASTM F2077-18 | 2019-01-14 | Complete | 2027-07-04 |
Regulations
FDA lists these classification regulations against ASTM F2077: 21 CFR 888.3030, 21 CFR 888.3060, 21 CFR 888.3080.
Product codes that cite ASTM F2077
7 FDA product codes cite ASTM F2077, including MAX, MQP, ODP, OVD, OVE.
- MAX Intervertebral Fusion Device With Bone Graft, Lumbar
- MQP Spinal Vertebral Body Replacement Device
- 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
- PLF Bone Wedge
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.