Last synced on 25 January 2026 at 3:41 am

DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160553
510(k) Type
Traditional
Applicant
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/30/2017
Days to Decision
487 days
Submission Type
Summary

DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160553
510(k) Type
Traditional
Applicant
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/30/2017
Days to Decision
487 days
Submission Type
Summary