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FDA 510(k)

EXPEDIUM SYSTEM, VIPER SYSTEM

K-Number: K110216 · 2011-04-01

ApplicantDepuy Spine, Inc.
Decision Date2011-04-01
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPEDIUM SYSTEM, VIPER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2011-04-01 under 510(k) number K110216. 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 SYSTEM, VIPER SYSTEM?

EXPEDIUM SYSTEM, VIPER SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-01. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K110216.

When did EXPEDIUM SYSTEM, VIPER SYSTEM receive FDA 510(k) clearance?

EXPEDIUM SYSTEM, VIPER SYSTEM received FDA 510(k) clearance on 2011-04-01, under 510(k) number K110216.

Who is the listed applicant for EXPEDIUM SYSTEM, VIPER SYSTEM?

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

What is the FDA product code for EXPEDIUM SYSTEM, VIPER SYSTEM?

The FDA product code for EXPEDIUM SYSTEM, VIPER SYSTEM is NKB.

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Other records listing Depuy Spine, Inc. 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.

K201831CONFIDENCE Spinal Cement SystemK111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMK121020VIPER SYSTEMK110353MOUNTAINEER OCT SPINAL SYSTEMK103133VEPER SYSTEM, EXPEDIUM SYSTEMK101993VIPER SYSTEM, EXPEDIUM 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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