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FDA 510(k)

Life Spine Lumbar Fixation System (SENTRY)

K-Number: K180166 · 2018-06-22

ApplicantLife Spine, Inc.
Decision Date2018-06-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Life Spine Lumbar Fixation System (SENTRY) is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2018-06-22 under approval number K180166. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Life Spine Lumbar Fixation System (SENTRY)?

Life Spine Lumbar Fixation System (SENTRY) is a medical device that received FDA 510(k) clearance on 2018-06-22. It is manufactured by Life Spine, Inc.. The 510(k) number is K180166.

When was Life Spine Lumbar Fixation System (SENTRY) approved by the FDA?

Life Spine Lumbar Fixation System (SENTRY) received FDA 510(k) clearance on 2018-06-22, under approval number K180166.

What company makes Life Spine Lumbar Fixation System (SENTRY)?

Life Spine Lumbar Fixation System (SENTRY) is manufactured by Life Spine, Inc..

What is the FDA product code for Life Spine Lumbar Fixation System (SENTRY)?

The FDA product code for Life Spine Lumbar Fixation System (SENTRY) is KWQ.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026)

Other Devices by Life Spine, Inc.

K161127The Small PLATEAU (PLATEAU-C) Spacer System K160066Pro-Link® Stand-Alone Cervical Spacer System K161037Tarsa-Link Stand-Alone Wedge Fixation System K153065The Hammertoe Correction System K153400ProLift Expandable System K172973Life Spine Foot and Ankle Plating System

View all 64 devices →

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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