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FDA 510(k)

MERCURY SPINAL SYSTEM

K-Number: K082353 · 2009-01-22

ApplicantSpinal Elements, Inc.
Decision Date2009-01-22
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MERCURY SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2009-01-22 under 510(k) number K082353. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERCURY SPINAL SYSTEM?

MERCURY SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-01-22. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K082353.

When did MERCURY SPINAL SYSTEM receive FDA 510(k) clearance?

MERCURY SPINAL SYSTEM received FDA 510(k) clearance on 2009-01-22, under 510(k) number K082353.

Who is the listed applicant for MERCURY SPINAL SYSTEM?

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

What is the FDA product code for MERCURY SPINAL SYSTEM?

The FDA product code for MERCURY SPINAL SYSTEM is NKB.

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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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