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FDA 510(k)

OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM

K-Number: K131810 · 2013-08-08

ApplicantOsseus Fusion Systems, LLC
Decision Date2013-08-08
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems, LLC. It received FDA 510(k) clearance on 2013-08-08 under 510(k) number K131810. 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 OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM?

OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-08. The listed applicant is Osseus Fusion Systems, LLC. The 510(k) number is K131810.

When did OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2013-08-08, under 510(k) number K131810.

Who is the listed applicant for OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM?

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

What is the FDA product code for OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM?

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

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Other records listing Osseus Fusion Systems, LLC 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

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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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