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FDA 510(k)

CLICK'X

K-Number: K992739 · 2000-02-08

ApplicantSynthes Spine
Decision Date2000-02-08
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CLICK'X is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 2000-02-08 under 510(k) number K992739. 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 CLICK'X?

CLICK'X is a medical device that received FDA 510(k) clearance on 2000-02-08. The listed applicant is Synthes Spine. The 510(k) number is K992739.

When did CLICK'X receive FDA 510(k) clearance?

CLICK'X received FDA 510(k) clearance on 2000-02-08, under 510(k) number K992739.

Who is the listed applicant for CLICK'X?

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

What is the FDA product code for CLICK'X?

The FDA product code for CLICK'X is MNH. This falls under the ENT category.

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Other records listing Synthes Spine 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.

K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSK120838SYNTHES MATRIX SYSTEMK111048SYNTHES SCOUT TACK FIXATIONK120928SYNTHES MATRIX SYSTEMK120571SYNTHES USS CONNECTORK113149SYNTHES USS CONNECTORS

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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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