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510(k) K201336

DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm by Synthes (USA) Products, LLC — Product Code JDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2020
Date Received
May 20, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nail, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K191463 — DePuy Synthes Hammertoe Continuous Compression Implant (February 26, 2020)
  • K192655 — Depuy Synthes Maxillofacial Portfolio - MR Conditional (December 30, 2019)

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  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)