Filler, Bone Void, Recombinant Platelet-Derived Growth Factor

OYR · Not classified · Unknown

Classification

FDA Product Code: OYR
Device class: Not classified
Regulation: —
Review panel: OR
Medical specialty: Unknown
Submission type: 3
GMP exempt: N
Life sustaining: Y
Implant: Y
Third-party review: N

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.

Market data

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

Source

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