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510(k) K231231

MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices by Paragon 28, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2023
Date Received
April 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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