FDA 510(k)

FORZA® XP Expandable Spacer System

K-Number: K172696 · 2018-01-19

Decision Date2018-01-19

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FORZA® XP Expandable Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2018-01-19 under 510(k) 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. The listed applicant is Orthofix, Inc.. The 510(k) number is K172696.

When did FORZA® XP Expandable Spacer System receive FDA 510(k) clearance?

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

Who is the listed applicant for FORZA® XP Expandable Spacer System?

The FDA 510(k) record lists Orthofix, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07282067Orthofix PhysioStim PEMF Ankle Fusion RetrospectiveACTIVE_NOT_RECRUITING

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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.