Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FORZA Ti Spacer System

K-Number: K203576 · 2021-03-03

ApplicantOrthofix, Inc.
Decision Date2021-03-03
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FORZA Ti Spacer System is a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2021-03-03 under approval number K203576. 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 Ti Spacer System?

FORZA Ti Spacer System is a medical device that received FDA 510(k) clearance on 2021-03-03. It is manufactured by Orthofix, Inc.. The 510(k) number is K203576.

When was FORZA Ti Spacer System approved by the FDA?

FORZA Ti Spacer System received FDA 510(k) clearance on 2021-03-03, under approval number K203576.

What company makes FORZA Ti Spacer System?

FORZA Ti Spacer System is manufactured by Orthofix, Inc..

What is the FDA product code for FORZA Ti Spacer System?

The FDA product code for FORZA Ti Spacer System is MAX.

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

View all 33 devices →

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.

↑