Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K242799

PliaFX Flo

510(k) number
K242799
Device name
PliaFX Flo
Applicant
Lifenet Health VA · US
Product code
MBP — Filler, Bone Void, Osteoinduction (W/O Human Growth
Decision date
2024-11-21
Date received
2024-09-17
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
510(k) Summary (official FDA PDF): K242799.pdf
Official FDA record: K242799
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.