Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device

K-Number: K173606 · 2018-04-13

ApplicantSeaSpine Orthopedics Corporation
Decision Date2018-04-13
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2018-04-13 under approval number K173606. 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 Intervertebral Body Fusion Device?

SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2018-04-13. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K173606.

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

SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device received FDA 510(k) clearance on 2018-04-13, under approval number K173606.

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

SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime 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, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device?

The FDA product code for SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime 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

K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device 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

View all 66 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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.

↑