FDA 510(k)

Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)

K-Nummer: K160663 · 2016-11-16

Entscheidungsdatum2016-11-16

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Spine, LLC. It received FDA 510(k) clearance on 2016-11-16 under 510(k) number K160663. 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 Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)?

Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is Evolution Spine, LLC. The 510(k) number is K160663.

When did Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) receive FDA 510(k) clearance?

Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) received FDA 510(k) clearance on 2016-11-16, under 510(k) number K160663.

Who is the listed applicant for Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)?

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

What is the FDA product code for Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)?

The FDA product code for Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) is MAX.

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Weitere Einträge mit Evolution Spine, LLC als Antragsteller

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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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