FDA 510(k)

Genesys Spine Apache® Anterior Lumbar Interbody Fusion System

K-Number: K161438 · 2016-11-08

Decision Date2016-11-08

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2016-11-08 under 510(k) number K161438. 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 Genesys Spine Apache® Anterior Lumbar Interbody Fusion System?

Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2016-11-08. The listed applicant is Genesys Spine. The 510(k) number is K161438.

When did Genesys Spine Apache® Anterior Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Genesys Spine Apache® Anterior Lumbar Interbody Fusion System received FDA 510(k) clearance on 2016-11-08, under 510(k) number K161438.

Who is the listed applicant for Genesys Spine Apache® Anterior Lumbar Interbody Fusion System?

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

What is the FDA product code for Genesys Spine Apache® Anterior Lumbar Interbody Fusion System?

The FDA product code for Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is MAX.

Related Clinical Trials

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.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION NCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITING NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITING NCT05037968MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral FusionRECRUITING

Other records listing Genesys Spine as applicant

K252322SIros-X System K242483Genesys Spine AIS-C II Cervical Interbody Fusion System K233595Genesys Spine Sacroiliac Joint Fusion System with Navigation K233594Genesys Spine 3DP AIS-C II Cervical Interbody System K220096Genesys Spine 3DP Lumbar Interbody System K191489Genesys Spine 3DP Cervical Interbody System

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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

View on FDA Database →

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