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Aap Cannulated Screw And Darco Headed Screw

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080101

by aap Implantate AG

Identifiers

510(k) Number
K080101 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Aap Cannulated Screw And Darco Headed Screw by aap Implantate AG — 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
aap Implantate AG

Sources (1)

  • FDA 510(k) K080101 24 fields · synced Jun 19, 2026