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FDA 510(k)

Life Spine SIMPACT Sacroiliac Joint Fixation System

K-Number: K201538 · 2020-09-18

ApplicantLife Spine, Inc.
Decision Date2020-09-18
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Life Spine SIMPACT Sacroiliac Joint Fixation System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2020-09-18 under approval number K201538. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Life Spine SIMPACT Sacroiliac Joint Fixation System?

Life Spine SIMPACT Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2020-09-18. It is manufactured by Life Spine, Inc.. The 510(k) number is K201538.

When was Life Spine SIMPACT Sacroiliac Joint Fixation System approved by the FDA?

Life Spine SIMPACT Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2020-09-18, under approval number K201538.

What company makes Life Spine SIMPACT Sacroiliac Joint Fixation System?

Life Spine SIMPACT Sacroiliac Joint Fixation System is manufactured by Life Spine, Inc..

What is the FDA product code for Life Spine SIMPACT Sacroiliac Joint Fixation System?

The FDA product code for Life Spine SIMPACT Sacroiliac Joint Fixation System is OUR.

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 NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07575750 Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) NOT_YET_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07492797 Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring NOT_YET_RECRUITING

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

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Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

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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