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FDA 510(k)

FLEX-NAILS

K-Number: K012161 · 2001-08-24

ApplicantFixano SA
Decision Date2001-08-24
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FLEX-NAILS is the device name listed in this FDA 510(k) record. The listed applicant is Fixano SA. It received FDA 510(k) clearance on 2001-08-24 under 510(k) number K012161. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEX-NAILS?

FLEX-NAILS is a medical device that received FDA 510(k) clearance on 2001-08-24. The listed applicant is Fixano SA. The 510(k) number is K012161.

When did FLEX-NAILS receive FDA 510(k) clearance?

FLEX-NAILS received FDA 510(k) clearance on 2001-08-24, under 510(k) number K012161.

Who is the listed applicant for FLEX-NAILS?

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 FLEX-NAILS?

The FDA product code for FLEX-NAILS is HTY.

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.

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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 FIXK012062PF2K012078RADIOFIX

Related Devices (Code: HTY)

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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

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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