FDA-recognized standard · Orthopedic
ASTM F1798: Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
Yes. FDA recognizes ASTM F1798-24 as recognition 11-422, entered 2025-05-26. FDA also lists ASTM F1798-21 (recognition 11-402, transition period ending 2027-07-04).
Recognized editions of ASTM F1798
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-422 | ASTM F1798-24 | 2025-05-26 | Complete | — |
| 11-402 | ASTM F1798-21 | 2023-12-18 | Complete | 2027-07-04 |
Regulations
FDA lists these classification regulations against ASTM F1798: 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070, 21 CFR 888.3075.
Product codes that cite ASTM F1798
7 FDA product codes cite ASTM F1798, including KWP, KWQ, NKB, NKG, NQP.
- KWP
- KWQ Appliance, Fixation, Spinal Intervertebral Body
- NKB Thoracolumbosacral Pedicle Screw System
- NKG Posterior Cervical Screw System
- NQP
- PGM
- PGN
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.