NDD — Cerclage, Fixation, Metallic Class II
FDA product code NDD covers "Cerclage, Fixation, Metallic", a Class II medical device regulated under 21 CFR 888.3010. 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
- NDD
- Device Class
- Class II
- Regulation Number
- 888.3010
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K003618 | whiteside biomechanics | WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-101 | May 23, 2001 |