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 a medical device manufactured by Naitive Technologies, Ltd.. It received FDA 510(k) clearance on 2025-09-02 under approval 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. It is manufactured by Naitive Technologies, Ltd.. The 510(k) number is K251408.
When was OsteoSight Hip (v1) approved by the FDA?
OsteoSight Hip (v1) received FDA 510(k) clearance on 2025-09-02, under approval number K251408.
What company makes OsteoSight Hip (v1)?
OsteoSight Hip (v1) is manufactured by Naitive Technologies, Ltd..
What is the FDA product code for OsteoSight Hip (v1)?
The FDA product code for OsteoSight Hip (v1) is SAO.
Related Devices (Code: SAO)
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.