FDA 510(k)

ACRON TLIF System

K-Number: K171151 · 2018-04-27

Decision Date2018-04-27

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ACRON TLIF System is a medical device manufactured by Spinemed Ges.M.B.H. It received FDA 510(k) clearance on 2018-04-27 under approval number K171151. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRON TLIF System?

ACRON TLIF System is a medical device that received FDA 510(k) clearance on 2018-04-27. It is manufactured by Spinemed Ges.M.B.H. The 510(k) number is K171151.

When was ACRON TLIF System approved by the FDA?

ACRON TLIF System received FDA 510(k) clearance on 2018-04-27, under approval number K171151.

What company makes ACRON TLIF System?

ACRON TLIF System is manufactured by Spinemed Ges.M.B.H.

What is the FDA product code for ACRON TLIF System?

The FDA product code for ACRON TLIF System is MAX.

Related Devices (Code: MAX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.