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FDA 510(k)

Leva Spacer System

K-Number: K153222 · 2016-04-15

ApplicantSpine Wave, Inc.
Decision Date2016-04-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Leva Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K153222. 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 Leva Spacer System?

Leva Spacer System is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Spine Wave, Inc.. The 510(k) number is K153222.

When did Leva Spacer System receive FDA 510(k) clearance?

Leva Spacer System received FDA 510(k) clearance on 2016-04-15, under 510(k) number K153222.

Who is the listed applicant for Leva Spacer System?

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

What is the FDA product code for Leva Spacer System?

The FDA product code for Leva Spacer System is MAX.

Other records listing Spine Wave, Inc. 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.

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemK261159Exceed® Biplanar Expandable Interbody SystemK243816Testa TP Pivoting Spacer SystemK251131Annex® 2 Adjacent Level SystemK243514Salvo® Robotic Navigation InstrumentsK240685Salvo® Spine System

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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

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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