OJH — Orthopedic Tray Class I
FDA product code OJH covers "Orthopedic Tray", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel.
Classification Details
- Product Code
- OJH
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- OR
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.