FDA 510(k)

FORZA PTC Spacer System

K-Number: K152475 · 2016-01-14

Decision Date2016-01-14

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FORZA PTC 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 2016-01-14 under 510(k) number K152475. 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 PTC Spacer System?

FORZA PTC Spacer System is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Orthofix, Inc.. The 510(k) number is K152475.

When did FORZA PTC Spacer System receive FDA 510(k) clearance?

FORZA PTC Spacer System received FDA 510(k) clearance on 2016-01-14, under 510(k) number K152475.

Who is the listed applicant for FORZA PTC 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 PTC Spacer System?

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

Related Clinical Trials

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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.