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FDA 510(k)

OSTEOMNI SPINAL FIXATION SYSTEM

K-Number: K254247 · 2026-02-24

ApplicantOsteomni, Inc.
Decision Date2026-02-24
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOMNI SPINAL FIXATION 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 2026-02-24 under 510(k) number K254247. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOMNI SPINAL FIXATION SYSTEM?

OSTEOMNI SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2026-02-24. The listed applicant is Osteomni, Inc.. The 510(k) number is K254247.

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

OSTEOMNI SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2026-02-24, under 510(k) number K254247.

Who is the listed applicant for OSTEOMNI SPINAL FIXATION 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 FIXATION SYSTEM?

The FDA product code for OSTEOMNI SPINAL FIXATION SYSTEM is NKB.

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.

K260850OSTEOMNI SPINAL CAGES SYSTEM

Related Devices (Code: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak 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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