K242984

BKS Revision System

510(k) number
K242984
Device name
BKS Revision System
Applicant
Ortho Development Corp. UT · US
Product code
JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
Decision date
2024-10-25
Date received
2024-09-26
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain

Also available from FDA: K242984.pdf

Official FDA record: K242984
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.