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FDA 510(k)

ProLift Wedge Expandable Spacer System

K-Number: K203361 · 2021-03-17

ApplicantLife Spine, Inc.
Decision Date2021-03-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ProLift Wedge Expandable Spacer System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2021-03-17 under approval number K203361. 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 ProLift Wedge Expandable Spacer System?

ProLift Wedge Expandable Spacer System is a medical device that received FDA 510(k) clearance on 2021-03-17. It is manufactured by Life Spine, Inc.. The 510(k) number is K203361.

When was ProLift Wedge Expandable Spacer System approved by the FDA?

ProLift Wedge Expandable Spacer System received FDA 510(k) clearance on 2021-03-17, under approval number K203361.

What company makes ProLift Wedge Expandable Spacer System?

ProLift Wedge Expandable Spacer System is manufactured by Life Spine, Inc..

What is the FDA product code for ProLift Wedge Expandable Spacer System?

The FDA product code for ProLift Wedge Expandable Spacer System is MAX.

Related Clinical Trials

NCT07082426 Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study ACTIVE_NOT_RECRUITING

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: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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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