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FDA 510(k)

The Small PLATEAU (PLATEAU-C) Spacer System

K-Number: K161127 · 2016-12-22

ApplicantLife Spine, Inc.
Decision Date2016-12-22
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Small PLATEAU (PLATEAU-C) Spacer System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2016-12-22 under approval number K161127. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Small PLATEAU (PLATEAU-C) Spacer System?

The Small PLATEAU (PLATEAU-C) Spacer System is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Life Spine, Inc.. The 510(k) number is K161127.

When was The Small PLATEAU (PLATEAU-C) Spacer System approved by the FDA?

The Small PLATEAU (PLATEAU-C) Spacer System received FDA 510(k) clearance on 2016-12-22, under approval number K161127.

What company makes The Small PLATEAU (PLATEAU-C) Spacer System?

The Small PLATEAU (PLATEAU-C) Spacer System is manufactured by Life Spine, Inc..

What is the FDA product code for The Small PLATEAU (PLATEAU-C) Spacer System?

The FDA product code for The Small PLATEAU (PLATEAU-C) Spacer System is ODP.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Life Spine, Inc.

K160066Pro-Link® Stand-Alone Cervical Spacer System K161037Tarsa-Link Stand-Alone Wedge Fixation System K153065The Hammertoe Correction System K153400ProLift Expandable System K172973Life Spine Foot and Ankle Plating System K173182ProLift® Expandable System

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Related Devices (Code: ODP)

K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated

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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