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FDA 510(k)

ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM

K-Number: K071890 · 2007-11-09

ApplicantAlphatec Spine, Inc.
Decision Date2007-11-09
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2007-11-09 under 510(k) number K071890. 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 ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM?

ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-11-09. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K071890.

When did ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2007-11-09, under 510(k) number K071890.

Who is the listed applicant for ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM?

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

What is the FDA product code for ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM?

The FDA product code for ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM is MNH. This falls under the ENT category.

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Other records listing Alphatec Spine, Inc. as applicant

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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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