FDA 510(k)

MOJAVE Expandable Interbody System

K-Number: K193203 · 2020-02-18

Decision Date2020-02-18

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MOJAVE Expandable Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2020-02-18 under 510(k) number K193203. 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 MOJAVE Expandable Interbody System?

MOJAVE Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2020-02-18. The listed applicant is K2m, Inc.. The 510(k) number is K193203.

When did MOJAVE Expandable Interbody System receive FDA 510(k) clearance?

MOJAVE Expandable Interbody System received FDA 510(k) clearance on 2020-02-18, under 510(k) number K193203.

Who is the listed applicant for MOJAVE Expandable Interbody System?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOJAVE Expandable Interbody System?

The FDA product code for MOJAVE Expandable Interbody System is MAX.

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Related Devices (Code: MAX)

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 Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.