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

K242187

BioBrace®

510(k) number
K242187
Device name
BioBrace®
Applicant
Conmed Corporation NY · US
Product code
OWW — Mesh, Surgical, Absorbable, Orthopaedics, Reinforcem
Decision date
2024-11-27
Date received
2024-07-25
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain

Also available from FDA: K242187.pdf

Official FDA record: K242187
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.