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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 the device name listed in this FDA 510(k) record. The listed applicant is Osteomni, Inc.. It received FDA 510(k) clearance on 2026-05-12 under 510(k) 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. The listed applicant is Osteomni, Inc.. The 510(k) number is K260850.

When did OSTEOMNI SPINAL CAGES SYSTEM receive FDA 510(k) clearance?

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

Who is the listed applicant for OSTEOMNI SPINAL CAGES SYSTEM?

The FDA 510(k) record lists Osteomni, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Osteomni, Inc. as applicant

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.

K254247OSTEOMNI SPINAL FIXATION SYSTEM

Related Devices (Code: ODP)

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Official Source

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

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