OWR
- Product code
- OWR
- Device name
- Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
For reinforcement of soft tissue where weakness exists in facial plastic surgery.
Official FDA classification page: OWR
Classification and pathway per current FDA publications. Data from openFDA (CC0).