Device type
Plate, Fixation, Bone
Product code HRS · Class II · 21 CFR 888.3030 · Orthopedic
Recent 510(k)s
Oct 29, 2026
K263602
Arthrex Plates, Screws and Pins, and Washers
Arthrex, Inc.
- HRS
- Class II
Oct 26, 2026
K261135
Trochlear Salvage Plating System
Skeletal Dynamics, Inc.
- HRS
- Class II
Oct 23, 2026
K263407
Tempo Plating System
Pace Surgical
- HRS
- Class II
Oct 23, 2026
K262779
ANTHEM™ Fracture System
Globus Medical, Inc.
- HRS
- Class II
Oct 15, 2026
K263269
Park's Pectus System
Tdm Co., Ltd.
- HRS
- Class II
Oct 2, 2026
K261611
TDM Large Bone Plate and Screw System
Tdm Co., Ltd.
- HRS
- Class II
Sep 28, 2026
K262649
Alians Forearm
Newclip Technics
- HRS
- Class II
Sep 23, 2026
K261892
ProRib Fixation System
Costa Surgical, Inc.
- HRS
- Class II
Sep 18, 2026
K262098
EnHAnce PEEK Bunion System
Nvision Biomedical Technologies
- HRS
- Class II
Sep 15, 2026
K262963
TMC Implant Fixation System
Treace Medical Concepts, Inc.
- HRS
- Class II
Sep 3, 2026
K261647
Tempo Plating System; Ultra Compression Screw System
Pace Surgical
- HRS
- Class II
Aug 28, 2026
K261830
FRAXION 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 Sirketi
- HRS
- Class II
Aug 19, 2026
K262537
Versalock Sterile Plating System
GM Dos Reis Industria e Comercio Ltda.
- HRS
- Class II
Recent recalls
Oct 30, 2026
Z-0318-2027
EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106
Smith & Nephew, Inc.
- HRS
- Class II
- Open, Classified
Oct 7, 2026
Z-3334-2026
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Wright Medical Technology, Inc.
- HRS
- Class II
- Ongoing