FDA 510(k)

FORZA SPACER SYSTEM

K-Number: K103111 · 2011-03-23

Decision Date2011-03-23

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FORZA 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 2011-03-23 under 510(k) number K103111. 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 SPACER SYSTEM?

FORZA SPACER SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-23. The listed applicant is Orthofix, Inc.. The 510(k) number is K103111.

When did FORZA SPACER SYSTEM receive FDA 510(k) clearance?

FORZA SPACER SYSTEM received FDA 510(k) clearance on 2011-03-23, under 510(k) number K103111.

Who is the listed applicant for FORZA 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 SPACER SYSTEM?

The FDA product code for FORZA SPACER SYSTEM is MAX.

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Other records listing Orthofix, Inc. as applicant

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Related Devices (Code: MAX)

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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.