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FDA 510(k)

DSS STABILIZATION SYSTEM-RIGID

K-Number: K120491 · 2012-05-09

ApplicantParadigm Spine, LLC
Decision Date2012-05-09
Product CodeMNH
Advisory CommitteeOR
DecisionUnknown

Device Summary

DSS STABILIZATION SYSTEM-RIGID is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Spine, LLC. It received FDA 510(k) clearance on 2012-05-09 under 510(k) number K120491. 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: Unknown.

Frequently Asked Questions

What is the DSS STABILIZATION SYSTEM-RIGID?

DSS STABILIZATION SYSTEM-RIGID is a medical device that received FDA 510(k) clearance on 2012-05-09. The listed applicant is Paradigm Spine, LLC. The 510(k) number is K120491.

When did DSS STABILIZATION SYSTEM-RIGID receive FDA 510(k) clearance?

DSS STABILIZATION SYSTEM-RIGID received FDA 510(k) clearance on 2012-05-09, under 510(k) number K120491.

Who is the listed applicant for DSS STABILIZATION SYSTEM-RIGID?

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

What is the FDA product code for DSS STABILIZATION SYSTEM-RIGID?

The FDA product code for DSS STABILIZATION SYSTEM-RIGID is MNH. This falls under the ENT category.

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Other records listing Paradigm Spine, 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.

K153302coflex-IFK112595COFLEX-FK113625DSS STABILIZATION SYSTEMK093438PARADIGM INTERSPINOUS FUSION PLATEK101083DSS STABILIZATION SYSTEMK091944MODIFICATION TO: DSS STABILIZATION 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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