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FDA 510(k)

INTEGRA(TM) CUSA NXT(TM) BONE TIPS

K-Number: K111741 · 2011-08-23

ApplicantIntegra Burlington Ma, Inc. (Formerly Integra Radi
Decision Date2011-08-23
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

INTEGRA(TM) CUSA NXT(TM) BONE TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Integra Burlington Ma, Inc. (Formerly Integra Radi. It received FDA 510(k) clearance on 2011-08-23 under 510(k) number K111741. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA(TM) CUSA NXT(TM) BONE TIPS?

INTEGRA(TM) CUSA NXT(TM) BONE TIPS is a medical device that received FDA 510(k) clearance on 2011-08-23. The listed applicant is Integra Burlington Ma, Inc. (Formerly Integra Radi. The 510(k) number is K111741.

When did INTEGRA(TM) CUSA NXT(TM) BONE TIPS receive FDA 510(k) clearance?

INTEGRA(TM) CUSA NXT(TM) BONE TIPS received FDA 510(k) clearance on 2011-08-23, under 510(k) number K111741.

Who is the listed applicant for INTEGRA(TM) CUSA NXT(TM) BONE TIPS?

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

What is the FDA product code for INTEGRA(TM) CUSA NXT(TM) BONE TIPS?

The FDA product code for INTEGRA(TM) CUSA NXT(TM) BONE TIPS 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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