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FDA 510(k)

ACCIN PEDICLE SCREW SYSTEM

K-Number: K073531 · 2008-02-04

ApplicantAccelerated Innovation, LLC
Decision Date2008-02-04
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACCIN PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accelerated Innovation, LLC. It received FDA 510(k) clearance on 2008-02-04 under 510(k) number K073531. 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 ACCIN PEDICLE SCREW SYSTEM?

ACCIN PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-04. The listed applicant is Accelerated Innovation, LLC. The 510(k) number is K073531.

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

ACCIN PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2008-02-04, under 510(k) number K073531.

Who is the listed applicant for ACCIN PEDICLE SCREW SYSTEM?

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

What is the FDA product code for ACCIN PEDICLE SCREW SYSTEM?

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

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Other records listing Accelerated Innovation, LLC 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.

K081127ACCIN TOTAL KNEE SYSTEMK080647ACCIN BIPOLAR HEAD SYSTEMK080539ACCIN UNIPOLAR HEAD SYSTEMK073120ACCIN PATELLOFEMORAL SYSTEMK073530ACCIN ANTERIOR CERVICAL PLATE SYSTEMK073068ACCIN HIP 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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