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
601–624 of 1311
Cleared Sep 17, 2003
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K032269
Synthes (Usa)
Orthopedic · 56d
Cleared Sep 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
K032032
Synthes (Usa)
Orthopedic · 65d
Cleared Aug 21, 2003
SYNTHES (USA) CALVICLE HOOK PLATE
K031677
Synthes (Usa)
Orthopedic · 83d
Cleared May 22, 2003
TEXAS T - PLATE
K031334
Biomet, Inc.
Orthopedic · 24d
Cleared May 05, 2003
SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES
K031178
Synthes (Usa)
Orthopedic · 21d
Cleared Apr 22, 2003
SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM
K030310
Synthes (Usa)
Orthopedic · 82d
Cleared Apr 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS
K030858
Synthes (Usa)
Orthopedic · 17d
Cleared Mar 20, 2003
SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
K030597
Synthes (Usa)
Orthopedic · 23d
Cleared Feb 05, 2003
SMALL TITANIUM WRIST FUSION PLATE
K023879
Synthes (Usa)
Orthopedic · 76d
Cleared Jan 28, 2003
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
K023802
Synthes (Usa)
Orthopedic · 75d
Cleared Jul 25, 2002
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
K022255
Synthes (Usa)
Orthopedic · 13d
Cleared Jul 24, 2002
SYNTHES IN-SITU BENDER/CUTTER
K021458
Synthes (Usa)
Orthopedic · 78d
Cleared Jun 12, 2002
SYNTHES 3.5 MM BROAD LC-DCP PLATES
K020872
Synthes (Usa)
Orthopedic · 86d
Cleared May 08, 2002
SYNTHES CALCANEAL PLATE
K020401
Synthes (Usa)
Orthopedic · 90d
Cleared Apr 22, 2002
DISTAL RADIUS PLATING SYSTEM
K020819
Biomet, Inc.
Orthopedic · 40d
Cleared Mar 21, 2002
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE
K014197
Synthes (Usa)
Orthopedic · 90d
Cleared Mar 18, 2002
OPENING/CLOSING WEDGE OSTETOMY PLATES
K014155
Arthrex, Inc.
Orthopedic · 89d
Cleared Jan 11, 2002
SYNTHES ANKLE ARTHRODESIS PLATE
K013415
Synthes (Usa)
Orthopedic · 88d
Cleared Dec 20, 2001
LORENZ LACTOSORB PANELS AND FASTENERS
K011139
Biomet, Inc.
Orthopedic · 251d
Cleared Dec 19, 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248
Synthes (Usa)
Orthopedic · 82d
Cleared Sep 28, 2001
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
K012114
Synthes (Usa)
Orthopedic · 84d
Cleared Aug 31, 2001
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
K012162
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Aug 09, 2001
SYNTHES LCP PROXIMAL TIBIA PLATE
K011978
Synthes (Usa)
Orthopedic · 45d
Cleared Jul 27, 2001
SYNTHES CURVED RECONSTRUCTION PLATE
K011334
Synthes (Usa)
Orthopedic · 86d