Recognized standard
13779-2 Third edition 2018-12
FDA recognition 8-493 · ISO · Materials
Key facts
| Recognition number | 8-493 |
|---|---|
| Designation | 13779-2 Third edition 2018-12 |
| Title | Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for single layer thermally sprayed hydroxyapatite coatings applied to metallic surgical implants. These requirements are intended to describe properties of the materials and to communicate these between organizations. These requirements are not written with the… |
At a glance
- 10–99 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: