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510(k) K181639

Panta 2 Arthrodesis Nail System by Integra LifeSciences Corporation — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2018
Date Received
June 21, 2018
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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