FDA 510(k)

FORZA XP Expandable Spacer System

K-Number: K213951 · 2022-01-05

Decision Date2022-01-05

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FORZA XP Expandable Spacer System is a medical device manufactured by Orthofix US, LLC. It received FDA 510(k) clearance on 2022-01-05 under approval number K213951. 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 2022-01-05. It is manufactured by Orthofix US, LLC. The 510(k) number is K213951.

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

FORZA XP Expandable Spacer System received FDA 510(k) clearance on 2022-01-05, under approval number K213951.

What company makes FORZA XP Expandable Spacer System?

FORZA XP Expandable Spacer System is manufactured by Orthofix US, LLC.

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 US, LLC

K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System K230252OFIX MIS App K252088Firebird SI Navigation System PMA P210035Stimulator, bone growth, non-invasive

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.