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.

Clearance details

Applicant: Osseus Fusions Systems, LLC
Product code: 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

K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18
K260036 — NeckTune 3D SA Cervical Cage2026-06-15

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.