K240947
- 510(k) number
- K240947
- Device name
- TENSOR® Suture Button System
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- HTN — Washer, Bolt Nut
- Decision date
- 2024-06-03
- Date received
- 2024-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240947.pdf
Official FDA record: K240947
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.