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Maestro Total Wrist

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042032

by Biomet, Inc.

Identifiers

510(k) Number
K042032 FDA 510(k)
FDA Product Code
JWJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3800 FDA 510(k)
Regulation Number
888.3800 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Maestro Total Wrist by Biomet, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K042032 24 fields · synced Jun 18, 2026