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FDA 510(k)

BIOFOAM BONE WEDGE MODEL ASSORTED

K-Number: K093950 · 2010-01-22

ApplicantWrightmedicaltechnologyinc
Decision Date2010-01-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOFOAM BONE WEDGE MODEL ASSORTED is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2010-01-22 under 510(k) number K093950. 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 MODEL ASSORTED?

BIOFOAM BONE WEDGE MODEL ASSORTED is a medical device that received FDA 510(k) clearance on 2010-01-22. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K093950.

When did BIOFOAM BONE WEDGE MODEL ASSORTED receive FDA 510(k) clearance?

BIOFOAM BONE WEDGE MODEL ASSORTED received FDA 510(k) clearance on 2010-01-22, under 510(k) number K093950.

Who is the listed applicant for BIOFOAM BONE WEDGE MODEL ASSORTED?

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 MODEL ASSORTED?

The FDA product code for BIOFOAM BONE WEDGE MODEL ASSORTED is HRS.

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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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