Recognized standard
18192-2 First edition 2010-06-15
FDA recognition 11-274 · ISO · Orthopedic
Key facts
| Recognition number | 11-274 |
|---|---|
| Designation | 18192-2 First edition 2010-06-15 |
| Title | Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 3 |
| Scope (excerpt) | This part of ISO 18192 defines a test procedure for spinal nucleus prostheses under the relative angular movement conditions specified by ISO 18192-1. This part of ISO 18192 is applicable to both lumbar and cervical prostheses. It is not applicable to total disc replacements and facet joint… |
At a glance
- None 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: