Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Pisces-SC Standalone Cervical Interbody System

K-Number: K261882 · 2026-08-21

ApplicantOsseus Fusions Systems, LLC
Decision Date2026-08-21
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pisces-SC Standalone Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusions Systems, LLC. It received FDA 510(k) clearance on 2026-08-21 under 510(k) number K261882. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pisces-SC Standalone Cervical Interbody System?

Pisces-SC Standalone Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Osseus Fusions Systems, LLC. The 510(k) number is K261882.

When did Pisces-SC Standalone Cervical Interbody System receive FDA 510(k) clearance?

Pisces-SC Standalone Cervical Interbody System received FDA 510(k) clearance on 2026-08-21, under 510(k) number K261882.

Who is the listed applicant for Pisces-SC Standalone Cervical Interbody System?

The FDA 510(k) record lists Osseus Fusions Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pisces-SC Standalone Cervical Interbody System?

The FDA product code for Pisces-SC Standalone Cervical Interbody System is OVE.

Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑