DePuy Synthes
Raynham, MA, US
DePuy Synthes appears in FDA device records in Raynham, MA. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for DePuy Synthes between 1979 and 2024. The busiest year on record is 2024, with 5. The most recent is 2024, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced System | HSB | Substantially Equivalent | |
| K233256 | Robotic Integration Instruments | OLO | Substantially Equivalent | |
| K233255 | CROSSNAV Navigation Enabled Instruments | OLO | Substantially Equivalent | |
| K233254 | TELIGEN System Navigation Ready Instruments | OLO | Substantially Equivalent | |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System | HRS | Substantially Equivalent | |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | KTT | Substantially Equivalent | |
| K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular System | HRS | Substantially Equivalent | |
| K213563 | DePuy Synthes Radial Head Replacement System | KWI | Substantially Equivalent | |
| K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) | HRS | Substantially Equivalent | |
| K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | HRS | Substantially Equivalent | |
| K201959 | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | HRS | Substantially Equivalent | |
| K201321 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System | HRS | Substantially Equivalent | |
| K190750 | DePuy Synthes Plates and Screws Portfolio | HRS | Substantially Equivalent | |
| K190409 | MatrixRIB Fixation System | HRS | Substantially Equivalent | |
| K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | HRS | Substantially Equivalent | |
| K172872 | DePuy Synthes Femoral Neck System | KTT | Substantially Equivalent | |
| K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins | JDP | Substantially Equivalent | |
| K163046 | DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long | HRS | Substantially Equivalent | |
| K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System | NKG | Substantially Equivalent | |
| K792352 | SYNTHES CERVICAL VERTABRAE PLATES | KWQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWQAppliance, Fixation, Spinal Intervertebral Body
- JDPCondylar Plate Fixation Implant
- OLOOrthopedic Stereotaxic Instrument
- HRSPlate, Fixation, Bone
- NKGPosterior Cervical Screw System
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- HSBRod, Fixation, Intramedullary And Accessories
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain