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)

SURESUBTRACTION ORTHO

K-Number: K130960 · 2013-08-20

ApplicantToshibamedical Systems Corporation
Decision Date2013-08-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURESUBTRACTION ORTHO is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2013-08-20 under 510(k) number K130960. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURESUBTRACTION ORTHO?

SURESUBTRACTION ORTHO is a medical device that received FDA 510(k) clearance on 2013-08-20. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K130960.

When did SURESUBTRACTION ORTHO receive FDA 510(k) clearance?

SURESUBTRACTION ORTHO received FDA 510(k) clearance on 2013-08-20, under 510(k) number K130960.

Who is the listed applicant for SURESUBTRACTION ORTHO?

The FDA 510(k) record lists Toshibamedical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURESUBTRACTION ORTHO?

The FDA product code for SURESUBTRACTION ORTHO is JAK.

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 Toshibamedical Systems Corporation 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.

K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemK173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0K173088Vitrea Software Toshiba Package VSTP-001AK173382Vantage Galan 3T, V4.6K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4K172863Infinix-i, INFX-8000V, V7.0

View all 52 devices →

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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.

↑