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FDA 510(k)

ACRON™ TLIF System

K-Number: K171151 · 2018-04-27

ApplicantSpinemed Ges.M.B.H
Decision Date2018-04-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACRON™ TLIF System is the device name listed in this FDA 510(k) record. The listed applicant is Spinemed Ges.M.B.H. It received FDA 510(k) clearance on 2018-04-27 under 510(k) 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. The listed applicant is Spinemed Ges.M.B.H. The 510(k) number is K171151.

When did ACRON™ TLIF System receive FDA 510(k) clearance?

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

Who is the listed applicant for ACRON™ TLIF System?

The FDA 510(k) record lists Spinemed Ges.M.B.H as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACRON™ TLIF System?

The FDA product code for ACRON™ TLIF System is MAX.

Related Devices (Code: MAX)

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.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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.

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