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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

K201336 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm". The FDA issued a decision of Substantially Equivalent on September 3, 2020. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Synthes (USA) Products, LLC has at least 10 other 510(k) clearances on record.

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

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)
  • 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)
  • K191463 — DePuy Synthes Hammertoe Continuous Compression Implant (February 26, 2020)

Other clearances for product code JDS

  • K243608 — TRIGEN Stable Lock Nut & Washer (June 12, 2025)
  • K240061 — TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System (September 20, 2024)
  • K241804 — TRIGEN INTERTAN 10S Nail System (August 22, 2024)
  • K233150 — NET BRAND Osteosynthesis Nailing System (February 20, 2024)
  • K230761 — TRIGEN META-NAIL Nail System (June 14, 2023)
  • K192003 — Auxein Nailing System (June 10, 2020)
  • K193533 — WIN Flexible Nail System (February 20, 2020)
  • K141737 — CONVENTUS PHS SYSTEM (April 8, 2015)
  • K123948 — CHINA NAILS AND ACCESSORIES (March 14, 2013)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)

FDA data resources