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

Platelet And Plasma Separator For Bone Graft Handling

21 CFR 864.9245 / Hematology
FDA source (opens on fda.gov)

ORG is the FDA product code for Platelet And Plasma Separator For Bone Graft Handling, a class II device type, regulated under 21 CFR 864.9245. FDA's definition for this code reads: "Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
ORG
Device name
Platelet And Plasma Separator For Bone Graft Handling
FDA definition
Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
Regulation
21 CFR 864.9245
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
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

12 of 90 companies shown, in name order