510(k) K211508

Steinmann Pins and Kirschner Wires by Stryker GmbH — Product Code JDW

K211508 is an FDA 510(k) premarket notification submitted by Stryker GmbH for the device "Steinmann Pins and Kirschner Wires". The FDA issued a decision of Substantially Equivalent on October 5, 2021. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Stryker GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2021
Date Received
May 14, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type