Recognized standard
8827 First edition 1988-10-15
FDA recognition 11-184 · ISO · Orthopedic
Key facts
| Recognition number | 11-184 |
|---|---|
| Designation | 8827 First edition 1988-10-15 |
| Title | Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard covers general requirements and the designation of dimensions and tolerances of staples with parallel legs intended for use in orthopaedic surgery. NOTE - The annex gives guidance on the selection and use of staples and does not form an integral part of this International… |
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: