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FDA 510(k)

Class II (US FDA 510(k))

510(k) K141420

by Medshape, Inc.

Identifiers

510(k) Number
K141420 FDA 510(k)
FDA Product Code
HTN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Fastforward by Medshape, 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
Medshape, Inc.

Sources (1)

  • FDA 510(k) K141420 24 fields · synced Jun 18, 2026