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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 the device name listed in this FDA 510(k) record. The listed applicant is Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2016-09-07 under 510(k) 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. The listed applicant is Additive Orthopaedics, LLC. The 510(k) number is K153207.

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

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

Who is the listed applicant for Additive Orthopaedics Bone Wedge 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 Bone Wedge System?

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

Other records listing Additive Orthopaedics, LLC as applicant

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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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