Recognized standard
F2624-12 (Reapproved 2020)
FDA recognition 11-280 · ASTM · Orthopedic
Key facts
| Recognition number | 11-280 |
|---|---|
| Designation | F2624-12 (Reapproved 2020) |
| Title | Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This test method describes methods to assess the static and dynamic properties of single level spinal constructs. 1.2 An option for assessing wear using a weight loss method and a dimensional analysis is given. This method, described herein, is used for the analysis of devices intended for… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: