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
889–912 of 1333
Cleared Jun 26, 2009
PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS
K090877
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Jun 26, 2009
ORTHOLOC ANKLE PLATING SYSTEM (APS)
K091243
Wrightmedicaltechnologyinc
Orthopedic · 59d
Cleared Jun 18, 2009
KENS INTERNAL FIXATION SYSTEM
K090786
Kens Finemedtech Sdn. Bhd
Orthopedic · 87d
Cleared Jun 15, 2009
CLAVICLE PLATING SYSTEM
K090289
Orthohelix Surgical Designs, Inc.
Orthopedic · 130d
Cleared Jun 04, 2009
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
K090675
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared May 20, 2009
HINGE PEDIATRIC PLATING SYSTEM
K090440
Pega Medical, Inc.
Orthopedic · 89d
Cleared May 08, 2009
ORTHOLOC 2.0/2.4 PLATE SYSTEM
K090692
Wrightmedicaltechnologyinc
Orthopedic · 53d
Cleared Apr 24, 2009
PEDIPLATES
K090666
OrthoPediatrics Corp.
Orthopedic · 42d
Cleared Apr 24, 2009
MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS
K090839
Syntec Scientific Corp.
Orthopedic · 28d
Cleared Apr 23, 2009
APTUS 2.0 RADIAL HEAD SYSTEM
K090053
Medartis AG
Orthopedic · 105d
Cleared Apr 01, 2009
SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM
K090047
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 31, 2009
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
K090492
DePuy Orthopaedics, Inc.
Orthopedic · 34d
Cleared Mar 20, 2009
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
K083843
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Mar 06, 2009
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
K083694
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 04, 2009
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
K083573
Synthes (Usa)
Orthopedic · 91d
Cleared Feb 26, 2009
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)
K083654
Zimmer, Inc.
Orthopedic · 78d
Cleared Feb 18, 2009
ANATOMIC LOCKING PLATING SYSTEM
K082300
DePuy Orthopaedics, Inc.
Orthopedic · 190d
Cleared Feb 06, 2009
MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50
K083447
Memometal Technologies
Orthopedic · 77d
Cleared Jan 30, 2009
ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM
K083286
OrthoPediatrics Corp.
Orthopedic · 86d
Cleared Jan 14, 2009
SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
K083025
Synthes (Usa)
Orthopedic · 96d
Cleared Jan 07, 2009
PERI-LOC BONE PLATING AND SCREW SYSTEM
K083032
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Dec 30, 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K083213
Synthes (Usa)
Orthopedic · 60d
Cleared Dec 19, 2008
PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
K081608
Toby Orthopaedics, LLC
Orthopedic · 193d
Cleared Dec 18, 2008
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS
K082527
Zimmer, Inc.
Orthopedic · 107d