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FDA 510(k)

BIOFOAM Bone Wedge

K-Number: K152062 · 2016-05-17

ApplicantWrightmedicaltechnologyinc
Decision Date2016-05-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOFOAM Bone Wedge is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2016-05-17 under approval number K152062. 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 BIOFOAM Bone Wedge?

BIOFOAM Bone Wedge is a medical device that received FDA 510(k) clearance on 2016-05-17. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K152062.

When was BIOFOAM Bone Wedge approved by the FDA?

BIOFOAM Bone Wedge received FDA 510(k) clearance on 2016-05-17, under approval number K152062.

What company makes BIOFOAM Bone Wedge?

BIOFOAM Bone Wedge is manufactured by Wrightmedicaltechnologyinc.

What is the FDA product code for BIOFOAM Bone Wedge?

The FDA product code for BIOFOAM Bone Wedge is HRS.

Other Devices by Wrightmedicaltechnologyinc

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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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