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FDA 510(k)

TRIFIX PEDICLE SPINAL SCREW ASSEMBLY

K-Number: K990657 · 1999-03-26

ApplicantCorin USA
Decision Date1999-03-26
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIFIX PEDICLE SPINAL SCREW ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 1999-03-26 under 510(k) number K990657. 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 PEDICLE SPINAL SCREW ASSEMBLY?

TRIFIX PEDICLE SPINAL SCREW ASSEMBLY is a medical device that received FDA 510(k) clearance on 1999-03-26. The listed applicant is Corin USA. The 510(k) number is K990657.

When did TRIFIX PEDICLE SPINAL SCREW ASSEMBLY receive FDA 510(k) clearance?

TRIFIX PEDICLE SPINAL SCREW ASSEMBLY received FDA 510(k) clearance on 1999-03-26, under 510(k) number K990657.

Who is the listed applicant for TRIFIX PEDICLE SPINAL SCREW ASSEMBLY?

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

What is the FDA product code for TRIFIX PEDICLE SPINAL SCREW ASSEMBLY?

The FDA product code for TRIFIX PEDICLE SPINAL SCREW ASSEMBLY is MNH. This falls under the ENT category.

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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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