K231850
- 510(k) number
- K231850
- Device name
- QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- NKG — Posterior Cervical Screw System
- Decision date
- 2024-03-14
- Date received
- 2023-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K231850.pdf
Official FDA record: K231850
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.