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510(k) K201944

DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) by Synthes (USA) Products, LLC — Product Code JEY

K201944 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)". The FDA issued a decision of Substantially Equivalent on September 10, 2020. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Synthes (USA) Products, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2020
Date Received
July 13, 2020
Clearance Type
Special
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

Other clearances by Synthes (USA) Products, LLC

  • K254087 — MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (June 11, 2026)
  • K212943 — SyntheCel Dura Repair (January 28, 2022)
  • K211313 — MAXFRAME Multi-Axial Correction System (aka MAXFRAME) (May 25, 2021)
  • K210408 — DePuy Synthes Variable Angle Locking Patella Plating System (April 8, 2021)
  • K210205 — DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Platin (March 26, 2021)
  • 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)
  • 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)

Other clearances for product code JEY

  • K252246 — Leforte MMF System (April 2, 2026)
  • K253373 — Southern Craniomaxillofacial (CMF) System (December 19, 2025)
  • K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsor (November 7, 2025)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K240651 — MRI Universal (July 12, 2024)
  • K233874 — tmCMF Solution (July 11, 2024)
  • K232889 — METICULY Patient-specific titanium maxillofacial mesh implant (April 30, 2024)
  • K232350 — Stryker Facial iD System (January 13, 2024)
  • K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (September 26, 2023)
  • K230733 — Stryker Resorbable Fixation System (August 5, 2023)

FDA data resources