K261882
- 510(k) number
- K261882
- Device name
- Pisces-SC Standalone Cervical Interbody System
- Applicant
- Osseus Fusions Systems, LLC TX · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2026-08-21
- Date received
- 2026-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K261882.pdf
Official FDA record: K261882
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.