FDA Product Code HRS: Plate, Fixation, Bone
FDA product code HRS covers bone fixation plates.
These implants stabilize fractures and osteotomies by bridging and compressing bone segments during healing. They are used across skeletal sites including the hand, wrist, foot, and ankle.
HRS devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include TriMed, Inc., Arthrex, Inc. and Tyber Medical, LLC.
1307
Total
1307
Cleared
116d
Avg days
1976
Since
1307 devices
Cleared
Jul 15, 2021
Acumed Clavicle Hook Plating System
Acumed, LLC
Orthopedic
125d
Cleared
Jun 29, 2021
Smith & Nephew Plates and Screws
Smith & Nephew, Inc.
Orthopedic
99d
Cleared
Apr 20, 2021
SOLE Medial Column Fusion Plate
Orthofix Srl
Orthopedic
89d
Cleared
Apr 08, 2021
DePuy Synthes Variable Angle Locking Patella Plating System
Synthes USA Products, LLC
Orthopedic
56d
Cleared
Mar 26, 2021
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
Synthes USA Products, LLC
Orthopedic
59d
Cleared
Mar 25, 2021
Arthrex Patella SuturePlates
Arthrex, Inc.
Orthopedic
85d
Cleared
Mar 12, 2021
CoLink Mfx Implant System
In2bones USA, LLC
Orthopedic
60d
Cleared
Mar 03, 2021
LOQTEQ Distal Lateral Femur Plate 4.5 System
Aap Implantate AG
Orthopedic
55d
Cleared
Feb 19, 2021
A.L.P.S. Clavicle Plating System
Biomet, Inc.
Orthopedic
25d
Cleared
Feb 03, 2021
Arthrex Pilon Fusion System
Arthrex, Inc.
Orthopedic
86d
Cleared
Jan 27, 2021
EVOS Large Fragment Plating System
Smith & Nephew, Inc.
Orthopedic
69d
Cleared
Jan 08, 2021
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
Wrightmedicaltechnologyinc
Orthopedic
242d