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FDA 510(k)

DDS STABILIZATION SYSTEM

K-Number: K080241 · 2008-11-28

ApplicantParadigm Spine, LLC
Decision Date2008-11-28
Product CodeNQP
Advisory CommitteeOR
DecisionUnknown

Device Summary

DDS STABILIZATION SYSTEM 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 2008-11-28 under 510(k) number K080241. The device is classified under product code NQP. It was reviewed by the OR advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the DDS STABILIZATION SYSTEM?

DDS STABILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-11-28. The listed applicant is Paradigm Spine, LLC. The 510(k) number is K080241.

When did DDS STABILIZATION SYSTEM receive FDA 510(k) clearance?

DDS STABILIZATION SYSTEM received FDA 510(k) clearance on 2008-11-28, under 510(k) number K080241.

Who is the listed applicant for DDS STABILIZATION SYSTEM?

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 DDS STABILIZATION SYSTEM?

The FDA product code for DDS STABILIZATION SYSTEM is NQP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-IFK120491DSS STABILIZATION SYSTEM-RIGIDK112595COFLEX-FK113625DSS STABILIZATION SYSTEMK093438PARADIGM INTERSPINOUS FUSION PLATEK101083DSS STABILIZATION SYSTEM

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Related Devices (Code: NQP)

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.

K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.K101704ZIMMER DTO PIN PRESS INSTRUMENTZimmer Spine, Inc.K101083DSS STABILIZATION SYSTEMParadigm Spine, LLCK092234DYNESYS TOP-LOADING SPINAL SYSTEMZimmer Spine, Inc.

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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