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FDA 510(k)

Additive Orthopaedics Bone Wedge System

K-Number: K153207 · 2016-09-07

ApplicantAdditive Orthopaedics, LLC
Decision Date2016-09-07
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Additive Orthopaedics Bone Wedge System is a medical device manufactured by Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2016-09-07 under approval number K153207. 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 Bone Wedge System?

Additive Orthopaedics Bone Wedge System is a medical device that received FDA 510(k) clearance on 2016-09-07. It is manufactured by Additive Orthopaedics, LLC. The 510(k) number is K153207.

When was Additive Orthopaedics Bone Wedge System approved by the FDA?

Additive Orthopaedics Bone Wedge System received FDA 510(k) clearance on 2016-09-07, under approval number K153207.

What company makes Additive Orthopaedics Bone Wedge System?

Additive Orthopaedics Bone Wedge System is manufactured by Additive Orthopaedics, LLC.

What is the FDA product code for Additive Orthopaedics Bone Wedge System?

The FDA product code for Additive Orthopaedics Bone Wedge System is HRS.

Related Clinical Trials

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Other Devices by Additive Orthopaedics, LLC

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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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