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

K230840

PMT Facet Fixation System, Lumbar (PMT FFS-LX)

510(k) number
K230840
Device name
PMT Facet Fixation System, Lumbar (PMT FFS-LX)
Applicant
Providence Medical Technology, Inc. CA · US
Product code
MRW — System, Facet Screw Spinal Device
Decision date
2023-12-19
Date received
2023-03-27
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Unknown
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K230840.pdf

Official FDA record: K230840
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.