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FDA 510(k)

EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM

K-Number: K131802 · 2013-09-12

ApplicantDepuy Spine, A Johnson & Johnson Company
Decision Date2013-09-12
Product CodeOSH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPEDIUM, VIPER. VIPER 2 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 2013-09-12 under 510(k) number K131802. The device is classified under product code OSH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM?

EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-12. The listed applicant is Depuy Spine, A Johnson & Johnson Company. The 510(k) number is K131802.

When did EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM receive FDA 510(k) clearance?

EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM received FDA 510(k) clearance on 2013-09-12, under 510(k) number K131802.

Who is the listed applicant for EXPEDIUM, VIPER. VIPER 2 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, VIPER. VIPER 2 SPINE SYSTEM?

The FDA product code for EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM is OSH.

Related Clinical Trials

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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.

K102249EXPEDIUM SPINE SYSTEMK071927MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENTK071495EXPEDIUM 4.5MM SPINE SYSTEM

Related Devices (Code: OSH)

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.

K153446OLYMPIC Posterior Spinal Fixation SystemAstura MedicalK132574PASS LP SPINAL SYSTEMMedicrea InternationalK132303IMPLANET SPINE SYSTEMImplanet, S.A.K132575PASS LP SPINAL SYSTEMMedicrea InternationalK131615POLARIS SPINAL SYSTEMBiomet Spine (Aka Ebi, LLC)K131784RANGE SPINAL SYSTEMK2m, Inc.

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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