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FDA 510(k)

The Cranial Fusion System

K-Number: K162266 · 2017-05-01

ApplicantLife Spine, Inc.
Decision Date2017-05-01
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Cranial Fusion System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2017-05-01 under approval number K162266. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Cranial Fusion System?

The Cranial Fusion System is a medical device that received FDA 510(k) clearance on 2017-05-01. It is manufactured by Life Spine, Inc.. The 510(k) number is K162266.

When was The Cranial Fusion System approved by the FDA?

The Cranial Fusion System received FDA 510(k) clearance on 2017-05-01, under approval number K162266.

What company makes The Cranial Fusion System?

The Cranial Fusion System is manufactured by Life Spine, Inc..

What is the FDA product code for The Cranial Fusion System?

The FDA product code for The Cranial Fusion System is NKG.

Related Clinical Trials

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Other Devices by Life Spine, Inc.

K161127The Small PLATEAU (PLATEAU-C) Spacer System 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

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Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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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