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FDA 510(k)

CONTOUR II SPINAL SYSTEM

K-Number: K053070 · 2006-02-13

ApplicantAltiva Corp.
Decision Date2006-02-13
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONTOUR II SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Altiva Corp.. It received FDA 510(k) clearance on 2006-02-13 under 510(k) number K053070. 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 CONTOUR II SPINAL SYSTEM?

CONTOUR II SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2006-02-13. The listed applicant is Altiva Corp.. The 510(k) number is K053070.

When did CONTOUR II SPINAL SYSTEM receive FDA 510(k) clearance?

CONTOUR II SPINAL SYSTEM received FDA 510(k) clearance on 2006-02-13, under 510(k) number K053070.

Who is the listed applicant for CONTOUR II SPINAL SYSTEM?

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

What is the FDA product code for CONTOUR II SPINAL SYSTEM?

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

Related Clinical Trials

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.

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Other records listing Altiva Corp. 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.

K070891ALTIVA CLASSIC ACP SYSTEMK061482ALTES BUTTRESS PLATING SYSTEMK051044ARCTEC SEMIRIGID PLATING SYSTEMK051216HYDRALOK SYSTEM

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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