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FDA 510(k)

MODIFICATION TO EASYS TRANSVERSE CONNECTION

K-Number: K031290 · 2003-05-13

ApplicantScient'X USA, Inc.
Decision Date2003-05-13
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO EASYS TRANSVERSE CONNECTION is the device name listed in this FDA 510(k) record. The listed applicant is Scient'X USA, Inc.. It received FDA 510(k) clearance on 2003-05-13 under 510(k) number K031290. 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 MODIFICATION TO EASYS TRANSVERSE CONNECTION?

MODIFICATION TO EASYS TRANSVERSE CONNECTION is a medical device that received FDA 510(k) clearance on 2003-05-13. The listed applicant is Scient'X USA, Inc.. The 510(k) number is K031290.

When did MODIFICATION TO EASYS TRANSVERSE CONNECTION receive FDA 510(k) clearance?

MODIFICATION TO EASYS TRANSVERSE CONNECTION received FDA 510(k) clearance on 2003-05-13, under 510(k) number K031290.

Who is the listed applicant for MODIFICATION TO EASYS TRANSVERSE CONNECTION?

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

What is the FDA product code for MODIFICATION TO EASYS TRANSVERSE CONNECTION?

The FDA product code for MODIFICATION TO EASYS TRANSVERSE CONNECTION is MNH. This falls under the ENT category.

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Other records listing Scient'X USA, 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.

K081548ANTERIOR BUTTRESS PLATEK080588SCIENT'X TRIBECA VBRK053292DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS

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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