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FDA 510(k)

INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP

K-Number: K113570 · 2012-02-22

ApplicantIntegra Burlington Ma, Inc.
Decision Date2012-02-22
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP is the device name listed in this FDA 510(k) record. The listed applicant is Integra Burlington Ma, Inc.. It received FDA 510(k) clearance on 2012-02-22 under 510(k) number K113570. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP?

INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP is a medical device that received FDA 510(k) clearance on 2012-02-22. The listed applicant is Integra Burlington Ma, Inc.. The 510(k) number is K113570.

When did INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP receive FDA 510(k) clearance?

INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP received FDA 510(k) clearance on 2012-02-22, under 510(k) number K113570.

Who is the listed applicant for INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP?

The FDA 510(k) record lists Integra Burlington Ma, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP?

The FDA product code for INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP is LFL.

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Related Devices (Code: LFL)

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.

K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLCK251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences CorporationK242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)Shanghai Saints Sages Surgical Co., Ltd.K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker InstrumentsK241700Tenex 2nd Generation SystemTrice Medical, Inc.K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation

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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