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FDA 510(k)

I-FUSE HAMMER TOE SYSTEMS

K-Number: K113006 · 2012-05-25

ApplicantOrthopro, LLC
Decision Date2012-05-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

I-FUSE HAMMER TOE SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Orthopro, LLC. It received FDA 510(k) clearance on 2012-05-25 under 510(k) number K113006. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-FUSE HAMMER TOE SYSTEMS?

I-FUSE HAMMER TOE SYSTEMS is a medical device that received FDA 510(k) clearance on 2012-05-25. The listed applicant is Orthopro, LLC. The 510(k) number is K113006.

When did I-FUSE HAMMER TOE SYSTEMS receive FDA 510(k) clearance?

I-FUSE HAMMER TOE SYSTEMS received FDA 510(k) clearance on 2012-05-25, under 510(k) number K113006.

Who is the listed applicant for I-FUSE HAMMER TOE SYSTEMS?

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

What is the FDA product code for I-FUSE HAMMER TOE SYSTEMS?

The FDA product code for I-FUSE HAMMER TOE SYSTEMS is HWC. This falls under the Cardiovascular category.

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Other records listing Orthopro, LLC as applicant

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Related Devices (Code: HWC)

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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.

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