K230639
- 510(k) number
- K230639
- Device name
- Align Cervical Interbody Fusion System
- Applicant
- Acuity Surgical Devices, LLC TX · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2023-12-01
- Date received
- 2023-03-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K230639.pdf
Official FDA record: K230639
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.