FDA.reportPublic FDA data

510(k) K233665

Device
DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
Applicant
DePuy Synthes
510(k) number
K233665
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-21
Date received
2023-11-15
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jeffrey Krawiec
Address
1301 Goshen Pkwy. West Chester PA US 19380 19380

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HRS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical2026-09-03
K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi2026-08-28
K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-08-19
K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.2026-08-13
K261511Xpert AnkleNewclip Technics2026-07-28
K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-07-21
K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.2026-07-16
K261191Alians Elbow SNewclip Technics2026-07-08
K261054RibPlate SystemStryker Leibinger GmbH & Co KG2026-07-01
K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG2026-06-26
K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (LI.T.S. GmbH2026-06-16
K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC2026-06-12
K260761APTUS Clavicle System 2.8Medartis AG2026-06-05
K261002Pectus Blu SystemBiomet Microfixation2026-06-02
K261038Xpert PFPNewclip Technics2026-05-29