HRS · Class II · 21 CFR 888.3030

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 Synthes (Usa), Wrightmedicaltechnologyinc and Arthrex, Inc..

1311
Total
1311
Cleared
116d
Avg days
1976
Since
1311 devices
169–192 of 1311
Cleared Mar 29, 2023
KLS Martin Level One Rib Fixation System
K222397
KLS-Martin L.P.
Orthopedic · 233d
Cleared Mar 29, 2023
WishBone Medical Plate and Screw System
K230527
Wishbone Medical, Inc.
Orthopedic · 30d
Cleared Mar 28, 2023
KLS Martin Pure Pectus System
K221938
KLS-Martin L.P.
Orthopedic · 270d
Cleared Mar 17, 2023
LOQTEQ® VA Elbow Plates 2.7/3.5 System
K230141
Aap Implantate AG
Orthopedic · 58d
Cleared Mar 07, 2023
Tyber Medical Anatomical Plating System
K222465
Tyber Medical, LLC
Orthopedic · 204d
Cleared Jan 27, 2023
Tibia and Fibula System
K213059
Auxein Medical Private Limited
Orthopedic · 492d
Cleared Jan 25, 2023
Advanced Bone Plate
K221150
Double Medical Technology, Inc.
Orthopedic · 280d
Cleared Jan 25, 2023
Medline UNITE® Ankle Fusion Plating System
K222665
Medline Industries, Inc.
Orthopedic · 141d
Cleared Jan 21, 2023
OIC Variable Angle Small Fragment Locking Plate System
K223118
Orthopaedic Implant Company
Orthopedic · 110d
Cleared Jan 18, 2023
Anatomic Bone Plate
K221088
Double Medical Technology, Inc.
Orthopedic · 280d
Cleared Jan 05, 2023
Treace Medical Concepts (TMC) Plating System
K221181
Treace Medical Concepts, Inc.
Orthopedic · 255d
Cleared Dec 21, 2022
TriMed Wrist Fixation System 3
K222637
TriMed, Inc.
Orthopedic · 112d
Cleared Nov 22, 2022
ARIX Rib System
K221412
Jeil Medical Corporation
Orthopedic · 190d
Cleared Nov 15, 2022
ALPHALOK Plating System
K221558
Vilex, LLC
Orthopedic · 168d
Cleared Nov 04, 2022
Humerus & Ulna System
K213108
Auxein Medical Private Limited
Orthopedic · 406d
Cleared Oct 27, 2022
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
K222282
Hospital Equipment Manufacturing Company
Orthopedic · 90d
Cleared Oct 18, 2022
EVOS Wrist Spanning Plate
K213123
Smith & Nephew, Inc.
Orthopedic · 386d
Cleared Oct 03, 2022
Varixis Elbow System
K213014
Auxein Medical Private Limited
Orthopedic · 378d
Cleared Oct 03, 2022
Arthrex 2.4 mm Volar Distal Radius Plate System
K222267
Arthrex, Inc.
Orthopedic · 67d
Cleared Sep 30, 2022
Arthrex 3.5 mm Locking Compression Plates
K222244
Arthrex, Inc.
Orthopedic · 66d
Cleared Sep 27, 2022
Medline UNITE® Medial Malleolus Peg Plate System
K221360
Medline Industries, LP
Orthopedic · 139d
Cleared Sep 20, 2022
DePuy Synthes 3.5mm Intrapelvic Acetabular System
K221809
DePuy Synthes
Orthopedic · 90d
Cleared Sep 02, 2022
Bonebridge Osteosynthesis Plating System
K213864
Bonebridge AG
Orthopedic · 266d
Cleared Aug 31, 2022
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
K210935
I.T.S. GmbH
Orthopedic · 520d