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510(k) K191463

DePuy Synthes Hammertoe Continuous Compression Implant by Synthes (USA) Products, LLC — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2020
Date Received
June 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • 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)
  • K192655 — Depuy Synthes Maxillofacial Portfolio - MR Conditional (December 30, 2019)

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  • K243658 — TMC Compression Implant System (December 26, 2024)
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  • K240212 — COGNiTiON™ Staple System (February 23, 2024)
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  • K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit (October 19, 2023)
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