FDA guidance
Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k))…
FDA guidance · Final · issued Nov 22, 2024
Key facts
| Title | Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Nov 22, 2024 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of Health Technology VI - Orthopedic Devices |
| Communication type | Guidance Document |
| Regulated product | Medical Devices |
| Topics | Premarket |
| Docket number | FDA-2023-D-0488 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- 10–99 Product codes referenced
- 1–9 Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents