Recognized standard
F3207-17
FDA recognition 15-54 · ASTM · Tissue Engineering
Key facts
| Recognition number | 15-54 |
|---|---|
| Designation | F3207-17 |
| Title | Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model |
| Standards developer | ASTM International |
| Specialty area | Tissue Engineering |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 Historically, the single-level rabbit posterolateral, or intertransverse, lumbar spine fusion model was developed and reported on by Dr. Scott Boden, et. al. (Emory Spine Center for Orthopedics) and the model has been proposed as a nonclinical model which may be used to replicate clinically… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: