K233332

Statera-C™ Spinal System

510(k) number
K233332
Device name
Statera-C™ Spinal System
Applicant
K&J Consulting Corp. PA · US
Product code
NKG — Posterior Cervical Screw System
Decision date
2023-11-27
Date received
2023-09-29
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K233332.pdf

Official FDA record: K233332
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.