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FDA 510(k)

FIXXSURE CROSS LINK

K-Number: K081331 · 2008-07-23

ApplicantSpineworks, LLC
Decision Date2008-07-23
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXXSURE CROSS LINK is the device name listed in this FDA 510(k) record. The listed applicant is Spineworks, LLC. It received FDA 510(k) clearance on 2008-07-23 under 510(k) number K081331. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXXSURE CROSS LINK?

FIXXSURE CROSS LINK is a medical device that received FDA 510(k) clearance on 2008-07-23. The listed applicant is Spineworks, LLC. The 510(k) number is K081331.

When did FIXXSURE CROSS LINK receive FDA 510(k) clearance?

FIXXSURE CROSS LINK received FDA 510(k) clearance on 2008-07-23, under 510(k) number K081331.

Who is the listed applicant for FIXXSURE CROSS LINK?

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

What is the FDA product code for FIXXSURE CROSS LINK?

The FDA product code for FIXXSURE CROSS LINK is MNH. This falls under the ENT category.

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Other records listing Spineworks, LLC 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.

K111166A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)K042600STANSION MATRIX

Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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