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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 the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2016-05-17 under 510(k) 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. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K152062.

When did BIOFOAM Bone Wedge receive FDA 510(k) clearance?

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

Who is the listed applicant for BIOFOAM Bone Wedge?

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

What is the FDA product code for BIOFOAM Bone Wedge?

The FDA product code for BIOFOAM Bone Wedge is HRS.

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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