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FDA 510(k)

RADIOFIX

K-Number: K012078 · 2001-09-27

ApplicantFixano SA
Decision Date2001-09-27
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RADIOFIX is the device name listed in this FDA 510(k) record. The listed applicant is Fixano SA. It received FDA 510(k) clearance on 2001-09-27 under 510(k) number K012078. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOFIX?

RADIOFIX is a medical device that received FDA 510(k) clearance on 2001-09-27. The listed applicant is Fixano SA. The 510(k) number is K012078.

When did RADIOFIX receive FDA 510(k) clearance?

RADIOFIX received FDA 510(k) clearance on 2001-09-27, under 510(k) number K012078.

Who is the listed applicant for RADIOFIX?

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

What is the FDA product code for RADIOFIX?

The FDA product code for RADIOFIX is KTT.

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 Fixano SA 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.

K023314MICROFIXK022771TWIN FIXK012062PF2K012161FLEX-NAILS

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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.

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