FDA 510(k)

Adaptix Interbody System mit Titan nanoLOCK Oberflächentechnologie

K-Nummer: K201267 · 2020-08-26

Entscheidungsdatum2020-08-26

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Adaptix Interbody System with Titan nanoLOCK Surface Technology is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K201267. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Adaptix Interbody System with Titan nanoLOCK Surface Technology?

Adaptix Interbody System with Titan nanoLOCK Surface Technology is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K201267.

When did Adaptix Interbody System with Titan nanoLOCK Surface Technology receive FDA 510(k) clearance?

Adaptix Interbody System with Titan nanoLOCK Surface Technology received FDA 510(k) clearance on 2020-08-26, under 510(k) number K201267.

Who is the listed applicant for Adaptix Interbody System with Titan nanoLOCK Surface Technology?

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

What is the FDA product code for Adaptix Interbody System with Titan nanoLOCK Surface Technology?

The FDA product code for Adaptix Interbody System with Titan nanoLOCK Surface Technology is MAX.

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Verwandte Geräte (Code: MAX)

K261049SCALA® TLSpineart SA 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 SystemSeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Offizielle Quelle

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