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FDA 510(k)

SIGN IM Nail

K-Number: K163589 · 2017-07-20

ApplicantSign Fracture Care International
Decision Date2017-07-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIGN IM Nail is the device name listed in this FDA 510(k) record. The listed applicant is Sign Fracture Care International. It received FDA 510(k) clearance on 2017-07-20 under 510(k) number K163589. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGN IM Nail?

SIGN IM Nail is a medical device that received FDA 510(k) clearance on 2017-07-20. The listed applicant is Sign Fracture Care International. The 510(k) number is K163589.

When did SIGN IM Nail receive FDA 510(k) clearance?

SIGN IM Nail received FDA 510(k) clearance on 2017-07-20, under 510(k) number K163589.

Who is the listed applicant for SIGN IM Nail?

The FDA 510(k) record lists Sign Fracture Care International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGN IM Nail?

The FDA product code for SIGN IM Nail is HSB.

Other records listing Sign Fracture Care International 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.

K153759SIGN Compression Screw System

Related Devices (Code: HSB)

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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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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