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FDA 510(k)

SPINAL EDGE TITAN PEDICLE SCREW SYSTEM

K-Number: K091110 · 2009-07-24

ApplicantSpinal Edge, LLC
Decision Date2009-07-24
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL EDGE TITAN PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Edge, LLC. It received FDA 510(k) clearance on 2009-07-24 under 510(k) number K091110. 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 SPINAL EDGE TITAN PEDICLE SCREW SYSTEM?

SPINAL EDGE TITAN PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-24. The listed applicant is Spinal Edge, LLC. The 510(k) number is K091110.

When did SPINAL EDGE TITAN PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

SPINAL EDGE TITAN PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2009-07-24, under 510(k) number K091110.

Who is the listed applicant for SPINAL EDGE TITAN PEDICLE SCREW SYSTEM?

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

What is the FDA product code for SPINAL EDGE TITAN PEDICLE SCREW SYSTEM?

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

Related Clinical Trials

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Other records listing Spinal Edge, 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.

K092774ATLAS INTERVERTEBRAL BODY CAGEK060916ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.

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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