K231704
- 510(k) number
- K231704
- Device name
- Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
- Applicant
- Life Spine, Inc. IL · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2023-10-19
- Date received
- 2023-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K231704.pdf
Official FDA record: K231704
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.