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
649–672 of 1333
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
Cleared Dec 02, 2013
1ST MTP PLATE
K133437
Osteomed
Orthopedic · 25d
Cleared Nov 19, 2013
A.L.P.S. CALCANEAL PLATING SYSTEM
K132898
Biomet Manufacturing Corp
Orthopedic · 64d
Cleared Nov 18, 2013
LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5
K131782
Aap Implantate AG
Orthopedic · 154d
Cleared Nov 18, 2013
FLOWER ANKLE PLATING SET
K133102
Flower Orthopedics Corporation
Orthopedic · 49d
Cleared Nov 04, 2013
ARIX HAND SYSTEM
K131566
Jeil Medical Corporation
Orthopedic · 158d
Cleared Nov 04, 2013
WOLF LONG BONE PLATE SYSTEM
K131834
Toby Orthopaedics
Orthopedic · 137d
Cleared Oct 29, 2013
2.5MM INLINE FUSION PLATE
K131867
Biomet, Inc.
Orthopedic · 127d
Cleared Oct 23, 2013
VARIAX 2 SYSTEM
K132502
Stryker Trauma AG
Orthopedic · 75d
Cleared Oct 08, 2013
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
K131186
Synthes USA Products, LLC
Orthopedic · 166d
Cleared Oct 03, 2013
AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5
K132554
Aap Implantate AG
Orthopedic · 50d
Cleared Oct 03, 2013
LOCKING PLATE SYSTEM
K132642
Beijing Libeier Bio-Engineering Institute Co., Ltd.
Orthopedic · 38d
Cleared Sep 25, 2013
ARTHREX COMPRESSION PLATES
K130510
Arthrex, Inc.
Orthopedic · 210d
Cleared Sep 17, 2013
MAXLOCK EXTREME SYSTEM
K132591
Orthohelix Surgical Designs, Inc.
Orthopedic · 29d