FDA 510(k)

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

K-Number: K160663 · 2016-11-16

Decision Date2016-11-16

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITING NCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITING NCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING NCT06904898CONDUIT vs. PEEK CagesACTIVE_NOT_RECRUITING

Other records listing Evolution Spine, LLC as applicant

K262094E3D™-C Interbody System K260038E3D™-C Interbody System K250167Evolution Spine Navigation Instruments K241846E3D™-C Interbody System K240368E3D™-A Interbody System K232432E3D™-A Interbody System

View all 14 devices →

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.