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FDA 510(k)

EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM

K-Number: K103490 · 2011-02-17

ApplicantJohnson & Johnson
Decision Date2011-02-17
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson. It received FDA 510(k) clearance on 2011-02-17 under 510(k) number K103490. 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 EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM?

EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-17. The listed applicant is Johnson & Johnson. The 510(k) number is K103490.

When did EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM receive FDA 510(k) clearance?

EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM received FDA 510(k) clearance on 2011-02-17, under 510(k) number K103490.

Who is the listed applicant for EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM?

The FDA 510(k) record lists Johnson & Johnson as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM?

The FDA product code for EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM is NKB.

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Other records listing Johnson & Johnson 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.

K113273SPOTLIGHT ACCESS SYSTEMK112913SPOTLIGHT ACCESS SYSTEMK113348COUGAR SYSTEMK110551EXPEDIUM SPINE SYSTEMK110694CONCORDE BULLET SPINAL SYSTEMK111571VIPER SYSTEMS

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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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