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FDA 510(k)

SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM

K-Number: K123164 · 2013-02-15

ApplicantSpinefrontier, Inc.
Decision Date2013-02-15
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinefrontier, Inc.. It received FDA 510(k) clearance on 2013-02-15 under 510(k) number K123164. 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 SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM?

SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-15. The listed applicant is Spinefrontier, Inc.. The 510(k) number is K123164.

When did SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2013-02-15, under 510(k) number K123164.

Who is the listed applicant for SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM?

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

What is the FDA product code for SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM?

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

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Other records listing Spinefrontier, 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.

K193106SpineFrontier Lumbar Interbody Fusion Device SystemK172484A-CIFT SoloFuseK132740SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEMK121060SPINE FRONTIER INDUS ACP SYSTEMK113518ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEMK111553SPINEFRONTIER LUMBAR IBF SYSTEM

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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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