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
529–552 of 1311
Cleared Mar 19, 2008
VARIAX DISTAL RADIUS TORX SCREWS
K080667
Howmedica Osteonics Corp.
Orthopedic · 9d
Cleared Feb 27, 2008
CHARLOTTE CLAW 3.5
K080295
Wrightmedicaltechnologyinc
Orthopedic · 23d
Cleared Feb 21, 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K073460
Synthes (Usa)
Orthopedic · 73d
Cleared Jan 07, 2008
BIOFOAM BONE WEDGE
K073535
Wrightmedicaltechnologyinc
Orthopedic · 21d
Cleared Dec 17, 2007
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K073186
Synthes (Usa)
Orthopedic · 34d
Cleared Nov 19, 2007
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS
K072818
Smith & Nephew, Inc.
Orthopedic · 48d
Cleared Oct 05, 2007
SMALL BONE WEDGE
K070592
Wrightmedicaltechnologyinc
Orthopedic · 217d
Cleared Aug 08, 2007
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K071563
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Jul 09, 2007
SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE
K071264
Synthes (Usa)
Orthopedic · 66d
Cleared Jun 22, 2007
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
K071184
Synthes (Usa)
Orthopedic · 53d
Cleared Jun 06, 2007
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES
K070946
Synthes (Usa)
Orthopedic · 63d
Cleared Mar 28, 2007
SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES
K070208
Synthes (Usa)
Orthopedic · 65d
Cleared Mar 15, 2007
STRYKER FOOT PLATING SYSTEM
K063875
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared Dec 18, 2006
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
K063049
Synthes (Usa)
Orthopedic · 75d
Cleared Nov 22, 2006
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
K063303
Zimmer, Inc.
Orthopedic · 21d
Cleared Oct 25, 2006
PROFYLE SYSTEM
K062498
Howmedica Osteonics Corp.
Orthopedic · 61d
Cleared Oct 19, 2006
SYNTHES LCP DISTAL FEMUR PLATES
K062564
Synthes (Usa)
Orthopedic · 49d
Cleared Sep 29, 2006
ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM
K062747
Arthrex, Inc.
Orthopedic · 15d
Cleared Sep 15, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K062216
Smith & Nephew, Inc.
Orthopedic · 45d
Cleared Sep 11, 2006
SYNTHES 3.5MM SPRING PLATE
K061973
Synthes (Usa)
Orthopedic · 61d
Cleared Sep 08, 2006
SYNTHES LCP ANKLE ARTHRODESIS PLATES
K061940
Synthes (Usa)
Orthopedic · 60d
Cleared Aug 04, 2006
SYNTHES (USA) CLAVICLE HOOK PLATES
K061753
Synthes (Usa)
Orthopedic · 44d
Cleared Jun 08, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY
K061352
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared May 19, 2006
AXSOS PLUS LOCKING PLATE SYSTEM
K061012
Howmedica Osteonics Corp.
Orthopedic · 37d