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FDA 510(k)

MODIFICATION TO: DSS STABILIZATION SYSTEM

K-Number: K090408 · 2009-03-20

ApplicantParadigm Spine, LLC
Decision Date2009-03-20
Product CodeNKB
Advisory CommitteeOR
DecisionUnknown

Device Summary

MODIFICATION TO: DSS 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 2009-03-20 under 510(k) number K090408. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the MODIFICATION TO: DSS STABILIZATION SYSTEM?

MODIFICATION TO: DSS STABILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-20. The listed applicant is Paradigm Spine, LLC. The 510(k) number is K090408.

When did MODIFICATION TO: DSS STABILIZATION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: DSS STABILIZATION SYSTEM received FDA 510(k) clearance on 2009-03-20, under 510(k) number K090408.

Who is the listed applicant for MODIFICATION TO: DSS 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 MODIFICATION TO: DSS STABILIZATION SYSTEM?

The FDA product code for MODIFICATION TO: DSS STABILIZATION SYSTEM is NKB.

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

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Related Devices (Code: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ 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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