Facial Implant

ODU · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.3500

Classification

FDA Product Code: ODU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.3500
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown