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FDA 510(k)

TRIFIX SPINAL FIXATION SYSTEM

K-Number: K010535 · 2001-03-19

ApplicantEndius, Inc.
Decision Date2001-03-19
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIFIX SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endius, Inc.. It received FDA 510(k) clearance on 2001-03-19 under 510(k) number K010535. 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 TRIFIX SPINAL FIXATION SYSTEM?

TRIFIX SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-19. The listed applicant is Endius, Inc.. The 510(k) number is K010535.

When did TRIFIX SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

TRIFIX SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2001-03-19, under 510(k) number K010535.

Who is the listed applicant for TRIFIX SPINAL FIXATION SYSTEM?

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

What is the FDA product code for TRIFIX SPINAL FIXATION SYSTEM?

The FDA product code for TRIFIX SPINAL FIXATION SYSTEM is MNH. This falls under the ENT category.

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Other records listing Endius, 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.

K080258MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEMK073510ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEMK073267ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEMK072840ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEMK070282ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEMK070367ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM

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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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