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..

1333
Total
1333
Cleared
115d
Avg days
1976
Since
1333 devices
625–648 of 1333
Cleared May 13, 2014
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
K140622
Biomet, Inc.
Orthopedic · 63d
Cleared May 08, 2014
AAP LOQTEC(R) OLECRANON PLATE
K140607
Aap Implantate AG
Orthopedic · 59d
Cleared May 07, 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814
Smith & Nephew, Inc.
Orthopedic · 36d
Cleared May 02, 2014
MATRIXRIB FIXATION SYSTEM
K133616
Synthes USA Products, LLC
Orthopedic · 158d
Cleared May 01, 2014
ORTHOPEDIC FIXATION SYSTEMS
K140216
Impact Medical, LLC
Orthopedic · 93d
Cleared Apr 25, 2014
PINIT SMALL BONE FUSION SYSTEM
K140617
Arthrosurface, Inc.
Orthopedic · 45d
Cleared Apr 17, 2014
PARALOCK PLATING SYSTEM / TUFFNEK SCREW
K140397
Paragon 28
Orthopedic · 58d
Cleared Apr 17, 2014
VARIAX 2 SYSTEM
K140769
Stryker Trauma AG
Orthopedic · 21d
Cleared Apr 07, 2014
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
K140069
Merete Medical GmbH
Orthopedic · 84d
Cleared Apr 07, 2014
FRAGMENT PLATE SYSTEM
K140372
Skeletal Dynamics, LLC
Orthopedic · 52d
Cleared Apr 03, 2014
VARIAX 2 SYSTEM
K140376
Stryker Trauma AG
Orthopedic · 48d
Cleared Apr 01, 2014
MODIFIED DISTAL RADIUS PLATING SYSTEM
K133939
Biomet
Orthopedic · 99d
Cleared Apr 01, 2014
VARIAX CLAVICLE HOOK PLATE
K140259
Stryker Trauma AG
Orthopedic · 57d
Cleared Mar 27, 2014
FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET
K133930
Flower Orthopedics Corporation
Orthopedic · 94d
Cleared Mar 24, 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
K133974
Stryker Leibinger GmbH
Orthopedic · 88d
Cleared Mar 13, 2014
EMERGE MEDICAL DISTAL RADIUS SET
K140107
Emerge Medical
Orthopedic · 57d
Cleared Mar 12, 2014
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
K140098
Emerge Medical
Orthopedic · 57d
Cleared Mar 12, 2014
EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
K140119
Emerge Medical
Orthopedic · 55d
Cleared Mar 04, 2014
LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM
K133525
Changzhou Dean Medical Instrument Co, Ltd.
Orthopedic · 109d
Cleared Mar 03, 2014
AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL
K133668
Shoulder Options, Inc.
Orthopedic · 94d
Cleared Feb 28, 2014
CHARLOTTE CLAW PLATE SYSTEM
K133715
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Feb 26, 2014
EMERGE MEDICAL BONE PLATE SYSTEM
K133536
Emerge Medical
Orthopedic · 100d
Cleared Feb 24, 2014
EXTRIMILOCK ANKLE PLATING SYSTEM
K133691
Osteomed LP
Orthopedic · 84d
Cleared Feb 12, 2014
CONVENTUS DRS
K131552
Conventus Orthopaedics
Orthopedic · 258d