OXB — Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction Class II
FDA product code OXB covers "Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants.
Classification Details
- Product Code
- OXB
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
For reinforcement of soft tissue where weakness exists during chest wall reconstruction.