OSTEOMNI SPINAL CAGES SYSTEM— 510(k) K260850

Name: FDA 510(k) clearance K260850
Creator: U.S. Food and Drug Administration
Published: 2026-05-12

Substantially Equivalent

Osteomni, Inc.

FDA 510(k) clearance K260850 for OSTEOMNI SPINAL CAGES SYSTEM, Substantially Equivalent on 2026-05-12. Applicant: Osteomni, Inc.. Device class: 2.

Summary

Osteomni's OSTEOMNI SPINAL CAGES SYSTEM is filed under ODP, cervical intervertebral fusion devices with bone graft.

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

Osteomni filed from Medley, Florida. Review took 57 calendar days (March 16 to May 12, 2026).

Clearance details

Applicant: Osteomni, Inc.
Product code: Product code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-03-16
Decision date: 2026-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medley, FL, US

Download summary PDF View on FDA.gov ↗

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K254247 — OSTEOMNI SPINAL FIXATION SYSTEM2026-02-24

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.