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FDA 510(k)

OSTEOMNI SPINAL CAGES SYSTEM

K-Number: K260850 · 2026-05-12

ApplicantOsteomni, Inc.
Decision Date2026-05-12
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOMNI SPINAL CAGES SYSTEM is a medical device manufactured by Osteomni, Inc.. It received FDA 510(k) clearance on 2026-05-12 under approval number K260850. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOMNI SPINAL CAGES SYSTEM?

OSTEOMNI SPINAL CAGES SYSTEM is a medical device that received FDA 510(k) clearance on 2026-05-12. It is manufactured by Osteomni, Inc.. The 510(k) number is K260850.

When was OSTEOMNI SPINAL CAGES SYSTEM approved by the FDA?

OSTEOMNI SPINAL CAGES SYSTEM received FDA 510(k) clearance on 2026-05-12, under approval number K260850.

What company makes OSTEOMNI SPINAL CAGES SYSTEM?

OSTEOMNI SPINAL CAGES SYSTEM is manufactured by Osteomni, Inc..

What is the FDA product code for OSTEOMNI SPINAL CAGES SYSTEM?

The FDA product code for OSTEOMNI SPINAL CAGES SYSTEM is ODP.

Related Devices (Code: ODP)

K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

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.

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