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FDA 510(k)

FORZA® XP Expandable Spacer System

K-Number: K172696 · 2018-01-19

ApplicantOrthofix, Inc.
Decision Date2018-01-19
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FORZA® XP Expandable Spacer System is a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2018-01-19 under approval number K172696. 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 FORZA® XP Expandable Spacer System?

FORZA® XP Expandable Spacer System is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Orthofix, Inc.. The 510(k) number is K172696.

When was FORZA® XP Expandable Spacer System approved by the FDA?

FORZA® XP Expandable Spacer System received FDA 510(k) clearance on 2018-01-19, under approval number K172696.

What company makes FORZA® XP Expandable Spacer System?

FORZA® XP Expandable Spacer System is manufactured by Orthofix, Inc..

What is the FDA product code for FORZA® XP Expandable Spacer System?

The FDA product code for FORZA® XP 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 Orthofix, Inc.

K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System K162638CETRA Anterior Cervical Plate System K161129PILLAR SA PTC K161280Cervical Stand Alone System K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System K152475FORZA PTC Spacer 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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