FDA 510(k)

spineEOS

K-Number: K160407 · 2016-04-08

Decision Date2016-04-08

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

spineEOS is the device name listed in this FDA 510(k) record. The listed applicant is Onefit Medical. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K160407. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the spineEOS?

spineEOS is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Onefit Medical. The 510(k) number is K160407.

When did spineEOS receive FDA 510(k) clearance?

spineEOS received FDA 510(k) clearance on 2016-04-08, under 510(k) number K160407.

Who is the listed applicant for spineEOS?

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

What is the FDA product code for spineEOS?

The FDA product code for spineEOS is LLZ.

Other records listing Onefit Medical as applicant

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.

K173390hipEOS K161828kneeEOS K161479hipEOS

Related Devices (Code: LLZ)

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, 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.