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FDA 510(k)

A-Link Z

K-Number: K201671 · 2021-05-04

ApplicantAcuity Surgical Devices, LLC
Decision Date2021-05-04
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A-Link Z is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K201671. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-Link Z?

A-Link Z is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Acuity Surgical Devices, LLC. The 510(k) number is K201671.

When did A-Link Z receive FDA 510(k) clearance?

A-Link Z received FDA 510(k) clearance on 2021-05-04, under 510(k) number K201671.

Who is the listed applicant for A-Link Z?

The FDA 510(k) record lists Acuity Surgical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-Link Z?

The FDA product code for A-Link Z is OVD.

Other records listing Acuity Surgical Devices, LLC as applicant

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Related Devices (Code: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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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