Recognized standard
16087 First edition 2013-10-01
FDA recognition 11-337 · ISO · Orthopedic
Key facts
| Recognition number | 11-337 |
|---|---|
| Designation | 16087 First edition 2013-10-01 |
| Title | Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This International Standard provides requirements for the clinical assessment of migration of orthopaedic implants with roentgen stereophotogrammetric analysis (RSA). |
At a glance
- None 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: