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..

1322
Total
1322
Cleared
116d
Avg days
1976
Since
1322 devices
625–648 of 1322
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
Cleared Feb 04, 2014
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
K132886
Smith & Nephew, Inc.
Orthopedic · 141d
Cleared Jan 28, 2014
EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM
K133541
Emerge Medical
Orthopedic · 71d
Cleared Jan 23, 2014
AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5
K133675
Aap Implantate AG
Orthopedic · 55d
Cleared Jan 17, 2014
BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS
K130614
Laura Cattabriga
Orthopedic · 316d
Cleared Jan 08, 2014
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
K133452
Emerge Medical
Orthopedic · 57d
Cleared Jan 07, 2014
D-RAD SMART PACK
K132296
Smith & Nephew, Inc.
Orthopedic · 168d
Cleared Jan 06, 2014
ACUMED HAND PLATING SYSTEM
K132769
Acumed, LLC
Orthopedic · 124d
Cleared Dec 24, 2013
LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE
K132787
Aap Implantate AG
Orthopedic · 109d
Cleared Dec 18, 2013
ARIX HAND LOCKING SYSTEM
K132876
Jeil Medical Corporation
Orthopedic · 96d
Cleared Dec 17, 2013
ZIMMER DISTAL RADIUS PLATING SYSTEM
K133246
Zimmer, Inc.
Orthopedic · 56d
Cleared Dec 13, 2013
CROSSCHECK PLATING SYSTEM
K132594
Solana Surgical, LLC
Orthopedic · 116d