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510(k) K183472

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional by Synthes (USA) Products, LLC — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2019
Date Received
December 14, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

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  • K191463 — DePuy Synthes Hammertoe Continuous Compression Implant (February 26, 2020)

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