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FDA 510(k)

FIXATE TISSUE BAND

K-Number: K113400 · 2011-12-16

ApplicantAnulex Technologies, Inc.
Decision Date2011-12-16
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FIXATE TISSUE BAND is the device name listed in this FDA 510(k) record. The listed applicant is Anulex Technologies, Inc.. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K113400. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXATE TISSUE BAND?

FIXATE TISSUE BAND is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Anulex Technologies, Inc.. The 510(k) number is K113400.

When did FIXATE TISSUE BAND receive FDA 510(k) clearance?

FIXATE TISSUE BAND received FDA 510(k) clearance on 2011-12-16, under 510(k) number K113400.

Who is the listed applicant for FIXATE TISSUE BAND?

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

What is the FDA product code for FIXATE TISSUE BAND?

The FDA product code for FIXATE TISSUE BAND is GZB.

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Other records listing Anulex Technologies, Inc. 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.

K121356MICRO/MINI N-PK(H) BONE ANCHORK121354MICRO/MINI N-PK(F) BONE ANCHORK113805FIXATE TISSUE BANDK112849FIXATE TISSUE BANDK111462FIXATE TISSUE BANDK100572VERSACLOSE, MODEL VC-200-01

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Related Devices (Code: GZB)

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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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