← Back to catalogue

FiberLocker Implant +2 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253867

by ZuriMED Technologies AG

Identifiers

510(k) Number
K253867 FDA 510(k)
FDA Product Code
OWX FDA 510(k)
Models / Variants

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3300 FDA 510(k)
Regulation Number
878.3300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

FiberLocker Implant +2 more models by ZuriMED Technologies AG — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Sources (1)

  • FDA 510(k) K253867 24 fields · synced Jun 18, 2026