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FDA 510(k)

Additive Orthopaedics Hammertoe Correction System

K-Number: K160264 · 2016-06-01

ApplicantAdditive Orthopaedics, LLC
Decision Date2016-06-01
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Additive Orthopaedics Hammertoe Correction System is a medical device manufactured by Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2016-06-01 under approval number K160264. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Additive Orthopaedics Hammertoe Correction System?

Additive Orthopaedics Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2016-06-01. It is manufactured by Additive Orthopaedics, LLC. The 510(k) number is K160264.

When was Additive Orthopaedics Hammertoe Correction System approved by the FDA?

Additive Orthopaedics Hammertoe Correction System received FDA 510(k) clearance on 2016-06-01, under approval number K160264.

What company makes Additive Orthopaedics Hammertoe Correction System?

Additive Orthopaedics Hammertoe Correction System is manufactured by Additive Orthopaedics, LLC.

What is the FDA product code for Additive Orthopaedics Hammertoe Correction System?

The FDA product code for Additive Orthopaedics Hammertoe Correction System is HTY.

Related Clinical Trials

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Other Devices by Additive Orthopaedics, LLC

K153207Additive Orthopaedics Bone Wedge System K163593Additive Orthopaedics Bunion System K170214Additive Orthopaedics Locking Lattice Plate K180239Additive Orthopaedics Patient Specific 3D Printed Bone Segments K211076Patient Specific Marking Guides

Related Devices (Code: HTY)

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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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