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FDA 510(k)

Additive Orthopaedics Bunion System

K-Number: K163593 · 2017-06-20

ApplicantAdditive Orthopaedics, LLC
Decision Date2017-06-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Additive Orthopaedics Bunion System is a medical device manufactured by Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2017-06-20 under approval number K163593. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Additive Orthopaedics Bunion System?

Additive Orthopaedics Bunion System is a medical device that received FDA 510(k) clearance on 2017-06-20. It is manufactured by Additive Orthopaedics, LLC. The 510(k) number is K163593.

When was Additive Orthopaedics Bunion System approved by the FDA?

Additive Orthopaedics Bunion System received FDA 510(k) clearance on 2017-06-20, under approval number K163593.

What company makes Additive Orthopaedics Bunion System?

Additive Orthopaedics Bunion System is manufactured by Additive Orthopaedics, LLC.

What is the FDA product code for Additive Orthopaedics Bunion System?

The FDA product code for Additive Orthopaedics Bunion System is HRS.

Related Clinical Trials

NCT05304819 PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair COMPLETED

Other Devices by Additive Orthopaedics, LLC

K153207Additive Orthopaedics Bone Wedge System K160264Additive Orthopaedics Hammertoe Correction System K170214Additive Orthopaedics Locking Lattice Plate K180239Additive Orthopaedics Patient Specific 3D Printed Bone Segments K211076Patient Specific Marking Guides

Related Devices (Code: HRS)

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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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