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FDA 510(k)

OMNIAXIAL CONNECTOR

K-Number: K993926 · 1999-12-17

ApplicantOrtho Tec, LLC
Decision Date1999-12-17
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNIAXIAL CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Tec, LLC. It received FDA 510(k) clearance on 1999-12-17 under 510(k) number K993926. 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 OMNIAXIAL CONNECTOR?

OMNIAXIAL CONNECTOR is a medical device that received FDA 510(k) clearance on 1999-12-17. The listed applicant is Ortho Tec, LLC. The 510(k) number is K993926.

When did OMNIAXIAL CONNECTOR receive FDA 510(k) clearance?

OMNIAXIAL CONNECTOR received FDA 510(k) clearance on 1999-12-17, under 510(k) number K993926.

Who is the listed applicant for OMNIAXIAL CONNECTOR?

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

What is the FDA product code for OMNIAXIAL CONNECTOR?

The FDA product code for OMNIAXIAL CONNECTOR is MNH. This falls under the ENT category.

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Other records listing Ortho Tec, 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.

K040514EOVIA CALCIUM PHOSPHATE CERAMICK040346MODIFICATION TO ORIA TOP CLIP SYSTEMK030958ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORSK031471ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01K023884MODIFICATION ORIA SPINAL SYSTEMK023378ORIA CLARIS

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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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