Pisces-SC Standalone Cervical Interbody System— 510(k) K261882

Name: FDA 510(k) clearance K261882
Creator: U.S. Food and Drug Administration
Published: 2026-08-21

Substantially Equivalent

Osseus Fusions Systems, LLC

FDA 510(k) clearance K261882 for Pisces-SC Standalone Cervical Interbody System, Substantially Equivalent on 2026-08-21. Applicant: Osseus Fusions Systems, LLC. Device class: 2.

Summary

Osseus Fusions Systems' Pisces-SC Standalone Cervical Interbody System is filed under product code OVE, cervical intervertebral fusion devices with integrated fixation. No model numbers are listed.

Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).

Osseus filed from Dallas, Texas. The decision came 77 calendar days after FDA received it (June 5 to August 21, 2026), and it was substantially equivalent.

Clearance details

Applicant: Osseus Fusions Systems, LLC
Product code: Product code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-06-05
Decision date: 2026-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVE

view all

K263113 — ZSAlign Cervical Interbody System2026-10-02
K262726 — NeckTune SA Cervical Cage2026-09-29
K263049 — SABER-C System2026-09-23
K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.