K223869
- 510(k) number
- K223869
- Device name
- ChoiceSpine Blackhawk Ti Cervical Spacer System
- Applicant
- Choice Spine, LLC TN · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2023-09-14
- Date received
- 2022-12-23
- 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: K223869.pdf
Official FDA record: K223869
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.