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FDA 510(k)

OSTEON BONE MINERAL ANALYZER

K-Number: K843922 · 1985-04-02

ApplicantOsteon, Inc.
Decision Date1985-04-02
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OSTEON BONE MINERAL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Osteon, Inc.. It received FDA 510(k) clearance on 1985-04-02 under 510(k) number K843922. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEON BONE MINERAL ANALYZER?

OSTEON BONE MINERAL ANALYZER is a medical device that received FDA 510(k) clearance on 1985-04-02. The listed applicant is Osteon, Inc.. The 510(k) number is K843922.

When did OSTEON BONE MINERAL ANALYZER receive FDA 510(k) clearance?

OSTEON BONE MINERAL ANALYZER received FDA 510(k) clearance on 1985-04-02, under 510(k) number K843922.

Who is the listed applicant for OSTEON BONE MINERAL ANALYZER?

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

What is the FDA product code for OSTEON BONE MINERAL ANALYZER?

The FDA product code for OSTEON BONE MINERAL ANALYZER is KGI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Osteon, 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.

K891582MODIFIED OSTEOANALYZER (# SPSHA110/220)

Related Devices (Code: KGI)

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.

K254072BoneVueCurvebeam AI / Curvebeam, LLCK252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK2510223D-SHAPER3D-Shaper Medical S.LK242295BunkerHill BMDBunkerHill HealthK243218TBS iNsight (V4)Medimaps Group SAK220402VirtuOstO.N. Diagnostics

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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