Product code OYR

Device name

Filler, Bone Void, Recombinant Platelet-Derived Growth Factor

Medical specialty

Unknown

Device class

N

Review panel

OR

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset