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FDA 510(k)

LxHA PEEK Lateral IBF System

K-Number: K190684 · 2019-06-17

ApplicantInnovasis, Inc.
Decision Date2019-06-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LxHA PEEK Lateral IBF System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2019-06-17 under approval number K190684. 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 LxHA PEEK Lateral IBF System?

LxHA PEEK Lateral IBF System is a medical device that received FDA 510(k) clearance on 2019-06-17. It is manufactured by Innovasis, Inc.. The 510(k) number is K190684.

When was LxHA PEEK Lateral IBF System approved by the FDA?

LxHA PEEK Lateral IBF System received FDA 510(k) clearance on 2019-06-17, under approval number K190684.

What company makes LxHA PEEK Lateral IBF System?

LxHA PEEK Lateral IBF System is manufactured by Innovasis, Inc..

What is the FDA product code for LxHA PEEK Lateral IBF System?

The FDA product code for LxHA PEEK Lateral IBF System is MAX.

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Other Devices by Innovasis, Inc.

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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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