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510(k) K190321

Pediatric Nailing PlatformFemur by OrthoPediatrics Corp. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2019
Date Received
February 13, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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