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FDA 510(k)

MODIFIED OSTEOANALYZER (# SPSHA110/220)

K-Number: K891582 · 1989-09-12

ApplicantOsteon, Inc.
Decision Date1989-09-12
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFIED OSTEOANALYZER (# SPSHA110/220) is the device name listed in this FDA 510(k) record. The listed applicant is Osteon, Inc.. It received FDA 510(k) clearance on 1989-09-12 under 510(k) number K891582. 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 MODIFIED OSTEOANALYZER (# SPSHA110/220)?

MODIFIED OSTEOANALYZER (# SPSHA110/220) is a medical device that received FDA 510(k) clearance on 1989-09-12. The listed applicant is Osteon, Inc.. The 510(k) number is K891582.

When did MODIFIED OSTEOANALYZER (# SPSHA110/220) receive FDA 510(k) clearance?

MODIFIED OSTEOANALYZER (# SPSHA110/220) received FDA 510(k) clearance on 1989-09-12, under 510(k) number K891582.

Who is the listed applicant for MODIFIED OSTEOANALYZER (# SPSHA110/220)?

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 MODIFIED OSTEOANALYZER (# SPSHA110/220)?

The FDA product code for MODIFIED OSTEOANALYZER (# SPSHA110/220) 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.

K843922OSTEON BONE MINERAL ANALYZER

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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