← Back to catalogue

Stryker Resorbable Fixation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231208

by Stryker Leibinger Gmbh & Co. Kg

Identifiers

510(k) Number
K231208 FDA 510(k)
FDA Product Code
HBW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5360 FDA 510(k)
Regulation Number
882.5360 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Stryker Resorbable Fixation System by Stryker Leibinger Gmbh & Co. Kg — Class II — FDA_510K — listed in FDA 510(k) — 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

FDA Applicant
Stryker Leibinger GmbH & Co KG

Sources (1)

  • FDA 510(k) K231208 24 fields · synced Jun 19, 2026