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FDA 510(k)

SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device

K-Number: K162351 · 2016-12-01

ApplicantSeaSpine Orthopedics Corporation
Decision Date2016-12-01
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K162351. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device?

SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K162351.

When did SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device receive FDA 510(k) clearance?

SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device received FDA 510(k) clearance on 2016-12-01, under 510(k) number K162351.

Who is the listed applicant for SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device?

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

What is the FDA product code for SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device?

The FDA product code for SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is OVD.

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Related Devices (Code: OVD)

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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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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