Home / 510(k) Clearances / K192655

510(k) K192655

Depuy Synthes Maxillofacial Portfolio - MR Conditional by Synthes (USA) Products, LLC — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2019
Date Received
September 25, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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  • K201346 — DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Scr (September 23, 2020)
  • K192702 — DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (September 18, 2020)
  • K201944 — DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) (September 10, 2020)
  • K201578 — DePuy Synthes Variable Angle Locking Patella Plating System (September 9, 2020)
  • K201336 — DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails (September 3, 2020)
  • K191463 — DePuy Synthes Hammertoe Continuous Compression Implant (February 26, 2020)

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