510(k) K213982

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires by Pacific Instruments — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2022
Date Received
December 20, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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