NDG — Washer, Bolt, Nut, Non-Spinal, Metallic Class II
FDA product code NDG covers "Washer, Bolt, Nut, Non-Spinal, Metallic", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NDG
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K052483 | synthes (usa) | SYNTHES (USA) SPHERICAL WASHERS | November 4, 2005 |