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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 a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2016-12-01 under approval 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. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K162351.

When was SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device approved by the FDA?

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

What company makes SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device?

SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is manufactured by SeaSpine Orthopedics Corporation.

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT03735667 ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement ACTIVE_NOT_RECRUITING NCT03507205 Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents COMPLETED NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by SeaSpine Orthopedics Corporation

K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone System K161535SeaSpine® NewPort™ Spinal System K160902Mariner Pedicle Screw System K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System

View all 66 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, Inc. K160597INDEPENDENCE MIS SpacersGlobus Medical, 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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