Company ยท US
DePuy Synthes
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2024. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 10 |
| OLO | Orthopedic Stereotaxic Instrument | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| JDP | Condylar Plate Fixation Implant | 1 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 |
| NKG | Posterior Cervical Screw System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2024 | K233696 | DePuy Synthes Retrograde Femoral Nail Advanced System DePuy Synthes | HSB |
| Jun 17, 2024 | K233256 | Robotic Integration Instruments DePuy Synthes, CH | OLO |
| Jun 17, 2024 | K233255 | CROSSNAV Navigation Enabled Instruments DePuy Synthes, CH | OLO |
| Jun 14, 2024 | K233254 | TELIGEN System Navigation Ready Instruments DePuy Synthes, CH | OLO |
| Mar 21, 2024 | K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System DePuy Synthes | HRS |
| Jul 26, 2023 | K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System DePuy Synthes | KTT |
| Sep 20, 2022 | K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular System DePuy Synthes | HRS |
| Mar 18, 2022 | K213563 | DePuy Synthes Radial Head Replacement System DePuy Synthes | KWI |
| Jun 2, 2021 | K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) DePuy Synthes | HRS |
| Dec 16, 2020 | K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System DePuy Synthes | HRS |
| Sep 11, 2020 | K201959 | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System DePuy Synthes | HRS |
| Jul 24, 2020 | K201321 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System DePuy Synthes | HRS |
| Jun 21, 2019 | K190750 | DePuy Synthes Plates and Screws Portfolio DePuy Synthes | HRS |
| May 3, 2019 | K190409 | MatrixRIB Fixation System DePuy Synthes | HRS |
| Dec 26, 2018 | K182783 | DePuy Synthes Trauma Orthopedic Nail Implants DePuy Synthes | HRS |
| Mar 5, 2018 | K172872 | DePuy Synthes Femoral Neck System DePuy Synthes, CH | KTT |
| Mar 29, 2017 | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins DePuy Synthes | JDP |
| Feb 9, 2017 | K163046 | DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long DePuy Synthes | HRS |
| Sep 3, 2015 | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System Depuy Synthes, Inc. | NKG |
| Dec 6, 1979 | K792352 | SYNTHES CERVICAL VERTABRAE PLATES DePuy Synthes | KWQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||