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FDA 510(k)

ZENITH PEDICLE SYSTEM

K-Number: K102636 · 2011-03-03

ApplicantApollo Spine, Inc.
Decision Date2011-03-03
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZENITH PEDICLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Spine, Inc.. It received FDA 510(k) clearance on 2011-03-03 under 510(k) number K102636. 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 ZENITH PEDICLE SYSTEM?

ZENITH PEDICLE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-03. The listed applicant is Apollo Spine, Inc.. The 510(k) number is K102636.

When did ZENITH PEDICLE SYSTEM receive FDA 510(k) clearance?

ZENITH PEDICLE SYSTEM received FDA 510(k) clearance on 2011-03-03, under 510(k) number K102636.

Who is the listed applicant for ZENITH PEDICLE SYSTEM?

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

What is the FDA product code for ZENITH PEDICLE SYSTEM?

The FDA product code for ZENITH PEDICLE SYSTEM is MNH. This falls under the ENT category.

Related Clinical Trials

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Other records listing Apollo Spine, 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.

K120340VENUS FACET SCREW SYSTEMK102121ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBARK101588ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICALK090751COMET ANTERIOR CERVICAL PLATE SYSTEMK082504APOLLO ANTERIOR CERVICAL PLATE 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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