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)

OsteoSight™ Hip (v1)

K-Number: K251408 · 2025-09-02

ApplicantNaitive Technologies, Ltd.
Decision Date2025-09-02
Product CodeSAO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OsteoSight™ Hip (v1) is the device name listed in this FDA 510(k) record. The listed applicant is Naitive Technologies, Ltd.. It received FDA 510(k) clearance on 2025-09-02 under 510(k) number K251408. The device is classified under product code SAO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoSight™ Hip (v1)?

OsteoSight™ Hip (v1) is a medical device that received FDA 510(k) clearance on 2025-09-02. The listed applicant is Naitive Technologies, Ltd.. The 510(k) number is K251408.

When did OsteoSight™ Hip (v1) receive FDA 510(k) clearance?

OsteoSight™ Hip (v1) received FDA 510(k) clearance on 2025-09-02, under 510(k) number K251408.

Who is the listed applicant for OsteoSight™ Hip (v1)?

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

What is the FDA product code for OsteoSight™ Hip (v1)?

The FDA product code for OsteoSight™ Hip (v1) is SAO.

Related Devices (Code: SAO)

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.

K253192DeepXray SpinaAlpha Intelligence Manifolds, Inc.

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.

↑