510(k) clearance
Pisces-SC Standalone Cervical Interbody System
- 510(k) number
- K261882
- Applicant
- Osseus Fusions Systems, LLC
- Decision date
- Aug 21, 2026
- Date received
- Jun 5, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OVE
- Device type
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device class
- Class II
- Regulation
- 21 CFR 888.3080
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Dallas, TX, US