OYR — Filler, Bone Void, Recombinant Platelet-Derived Growth Factor Class N

FDA Device Classification

FDA product code OYR covers "Filler, Bone Void, Recombinant Platelet-Derived Growth Factor", a Class N medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

Product Code
OYR
Device Class
Class N
Regulation Number
Submission Type
Review Panel
OR
Medical Specialty
Unknown
Implant
Yes

Definition

For use as an alternative to autograft in hindfoot and ankle fusion procedures that require supplemental graft material, including tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions.