K233414
- 510(k) number
- K233414
- Device name
- Shoreline ACS Interbody System; Shoreline RT Interbody System
- Applicant
- SeaSpine Orthopedics Corporation CA · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2023-11-28
- Date received
- 2023-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233414.pdf
Official FDA record: K233414
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.