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

K240392

JAZZ Spinal System

510(k) number
K240392
Device name
JAZZ Spinal System
Applicant
Implanet FR
Product code
NKB — Thoracolumbosacral Pedicle Screw System
Decision date
2024-05-06
Date received
2024-02-08
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain

Also available from FDA: K240392.pdf

Official FDA record: K240392
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.