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

K233966

Anterior Spine Truss System-Stand Alone (ASTS-SA)

510(k) number
K233966
Device name
Anterior Spine Truss System-Stand Alone (ASTS-SA)
Applicant
4Web Medical, Inc. TX · US
Product code
OVD — Intervertebral Fusion Device With Integrated Fixatio
Decision date
2024-04-22
Date received
2023-12-15
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K233966.pdf

Official FDA record: K233966
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.