Chrysalis Intelligence · Sponsors · DePuy Synthes

DePuy Synthes

West Chester, PA, US · 12 510(k) clearances

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Total clearances
12
2020-07-24 → 2024-08-01
Last 12 months
0
Product codes
5
Most recent
2024-08-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRS Plate, Fixation, Bone Class II Orthopedic 6 2024-03-21
OLO Orthopedic Stereotaxic Instrument Class II Neurology 3 2024-06-17
HSB Rod, Fixation, Intramedullary And Accessories Class II Orthopedic 1 2024-08-01
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class II Orthopedic 1 2023-07-26
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Class II Orthopedic 1 2022-03-18
Filings

All 510(k) clearances (12)

Date K-number Device Code Class Specialty
2024-08-01 K233696 DePuy Synthes Retrograde Femoral Nail Advanced System HSB Class II Orthopedic
2024-06-17 K233256 Robotic Integration Instruments OLO Class II Neurology
2024-06-17 K233255 CROSSNAV Navigation Enabled Instruments OLO Class II Neurology
2024-06-14 K233254 TELIGEN System Navigation Ready Instruments OLO Class II Neurology
2024-03-21 K233665 DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System HRS Class II Orthopedic
2023-07-26 K231922 DEPUY SYNTHES MAXFRAME AUTOSTRUT System KTT Class II Orthopedic
2022-09-20 K221809 DePuy Synthes 3.5mm Intrapelvic Acetabular System HRS Class II Orthopedic
2022-03-18 K213563 DePuy Synthes Radial Head Replacement System KWI Class II Orthopedic
2021-06-02 K211051 DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) HRS Class II Orthopedic
2020-12-16 K203414 DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System HRS Class II Orthopedic
2020-09-11 K201959 DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System HRS Class II Orthopedic
2020-07-24 K201321 DePuy Synthes 2.7mm VA LCP Clavicle Plate System HRS Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence