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FDA 510(k)

MAESTRO CARPAL HEMIARTHROPLASTY

K-Number: K050028 · 2005-03-25

ApplicantBiomet Manufacturing, Inc.
Decision Date2005-03-25
Product CodeKWN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAESTRO CARPAL HEMIARTHROPLASTY is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2005-03-25 under 510(k) number K050028. The device is classified under product code KWN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAESTRO CARPAL HEMIARTHROPLASTY?

MAESTRO CARPAL HEMIARTHROPLASTY is a medical device that received FDA 510(k) clearance on 2005-03-25. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K050028.

When did MAESTRO CARPAL HEMIARTHROPLASTY receive FDA 510(k) clearance?

MAESTRO CARPAL HEMIARTHROPLASTY received FDA 510(k) clearance on 2005-03-25, under 510(k) number K050028.

Who is the listed applicant for MAESTRO CARPAL HEMIARTHROPLASTY?

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

What is the FDA product code for MAESTRO CARPAL HEMIARTHROPLASTY?

The FDA product code for MAESTRO CARPAL HEMIARTHROPLASTY is KWN.

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Other records listing Biomet Manufacturing, Inc. as applicant

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.

K130390COMPREHENSIVE CONVERTIBLE GLENOIDK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSK113121COMPREHENSIVE REVERSE SHOULDERK080685HIPLOC COMPRESSION HIP SCREWK080088BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTSK071271BIOMET CABLE SYSTEM

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Related Devices (Code: KWN)

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.

K080997ASCENSION PYROCARBON LUNATEAscension Orthopedics, Inc.K864491SWANSON TITANIUM CARPAL LUNATE IMPLANTDow Corning WrightK790793AMC R METACARPAL COMPONENTHowmedica Corp.

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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