K230478
- 510(k) number
- K230478
- Device name
- Acro Composites Interbody System
- Applicant
- Acro Composites, LLC OH · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2023-10-19
- Date received
- 2023-02-22
- 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: K230478.pdf
Official FDA record: K230478
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.