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FDA 510(k)

SCARLET AL-T

K-Number: K192993 · 2020-01-22

ApplicantSpineart
Decision Date2020-01-22
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCARLET AL-T is the device name listed in this FDA 510(k) record. The listed applicant is Spineart. It received FDA 510(k) clearance on 2020-01-22 under 510(k) number K192993. 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 SCARLET AL-T?

SCARLET AL-T is a medical device that received FDA 510(k) clearance on 2020-01-22. The listed applicant is Spineart. The 510(k) number is K192993.

When did SCARLET AL-T receive FDA 510(k) clearance?

SCARLET AL-T received FDA 510(k) clearance on 2020-01-22, under 510(k) number K192993.

Who is the listed applicant for SCARLET AL-T?

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

What is the FDA product code for SCARLET AL-T?

The FDA product code for SCARLET AL-T is OVD.

Other records listing Spineart 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.

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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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