QBO — Instruments Designed For Press-Fit Osteochondral Implants Class II
FDA product code QBO covers "Instruments Designed For Press-Fit Osteochondral Implants", a Class II medical device regulated under 21 CFR 888.4505. Submissions are reviewed by the Orthopedic panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QBO
- Device Class
- Class II
- Regulation Number
- 888.4505
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Definition
The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.