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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 the device name listed in this FDA 510(k) record. The listed applicant is Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2017-06-20 under 510(k) 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. The listed applicant is Additive Orthopaedics, LLC. The 510(k) number is K163593.

When did Additive Orthopaedics Bunion System receive FDA 510(k) clearance?

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

Who is the listed applicant for Additive Orthopaedics Bunion System?

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

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

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

Other records listing Additive Orthopaedics, LLC as applicant

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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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