510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OYRNot classified

Filler, Bone Void, Recombinant Platelet-Derived Growth Factor

Unknown
FDA source (opens on fda.gov)

OYR is the FDA product code for Filler, Bone Void, Recombinant Platelet-Derived Growth Factor. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OYR
Device name
Filler, Bone Void, Recombinant Platelet-Derived Growth Factor
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
Contact ODE
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OYR.