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FDA 510(k)

EXPEDIUM 4.5MM SPINE SYSTEM

K-Number: K071495 · 2007-06-29

ApplicantDepuy Spine, A Johnson & Johnson Company
Decision Date2007-06-29
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPEDIUM 4.5MM SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K071495. 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 4.5MM SPINE SYSTEM?

EXPEDIUM 4.5MM SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Depuy Spine, A Johnson & Johnson Company. The 510(k) number is K071495.

When did EXPEDIUM 4.5MM SPINE SYSTEM receive FDA 510(k) clearance?

EXPEDIUM 4.5MM SPINE SYSTEM received FDA 510(k) clearance on 2007-06-29, under 510(k) number K071495.

Who is the listed applicant for EXPEDIUM 4.5MM SPINE SYSTEM?

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

What is the FDA product code for EXPEDIUM 4.5MM SPINE SYSTEM?

The FDA product code for EXPEDIUM 4.5MM SPINE SYSTEM is NKB.

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.

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Other records listing Depuy Spine, A Johnson & Johnson Company 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.

K131802EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEMK102249EXPEDIUM SPINE SYSTEMK071927MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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