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FDA 510(k)

Steerable Plateau Ti

K-Number: K193521 · 2020-02-06

ApplicantLife Spine, Inc.
Decision Date2020-02-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Steerable Plateau Ti is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2020-02-06 under approval number K193521. 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 Steerable Plateau Ti?

Steerable Plateau Ti is a medical device that received FDA 510(k) clearance on 2020-02-06. It is manufactured by Life Spine, Inc.. The 510(k) number is K193521.

When was Steerable Plateau Ti approved by the FDA?

Steerable Plateau Ti received FDA 510(k) clearance on 2020-02-06, under approval number K193521.

What company makes Steerable Plateau Ti?

Steerable Plateau Ti is manufactured by Life Spine, Inc..

What is the FDA product code for Steerable Plateau Ti?

The FDA product code for Steerable Plateau Ti is MAX.

Other Devices by Life Spine, 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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