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FDA 510(k)

NFIX FUSION SYSTEM

K-Number: K053623 · 2006-07-12

ApplicantN-Spine, Inc.
Decision Date2006-07-12
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NFIX FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is N-Spine, Inc.. It received FDA 510(k) clearance on 2006-07-12 under 510(k) number K053623. 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 NFIX FUSION SYSTEM?

NFIX FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-12. The listed applicant is N-Spine, Inc.. The 510(k) number is K053623.

When did NFIX FUSION SYSTEM receive FDA 510(k) clearance?

NFIX FUSION SYSTEM received FDA 510(k) clearance on 2006-07-12, under 510(k) number K053623.

Who is the listed applicant for NFIX FUSION SYSTEM?

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

What is the FDA product code for NFIX FUSION SYSTEM?

The FDA product code for NFIX FUSION SYSTEM is MNH. This falls under the ENT category.

Related Clinical Trials

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.

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Other records listing N-Spine, 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.

K072685NGARDE SYSTEMK061774NFIX II PEDICLE SCREW SYSTEM

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

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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