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
649–672 of 1311
Cleared Apr 14, 1998
DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
K980368
Depuy, Inc.
Orthopedic · 74d
Cleared Mar 18, 1998
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
K974908
Synthes (Usa)
Orthopedic · 77d
Cleared Jan 30, 1998
LACTOSORB PANELS
K974309
Biomet, Inc.
Orthopedic · 74d
Cleared Sep 11, 1997
ALTA PLATING SYSTEM
K972479
Howmedica Corp.
Orthopedic · 72d
Cleared Aug 19, 1997
LACTOSORB TRAUMA PLATING SYSTEM
K971870
Biomet, Inc.
Orthopedic · 90d
Cleared Mar 25, 1997
SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K963325
Synthes (Usa)
Orthopedic · 214d
Cleared Dec 17, 1996
SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K962894
Synthes (Usa)
Orthopedic · 145d
Cleared Nov 27, 1996
SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM
K963798
Synthes (Usa)
Orthopedic · 65d
Cleared Sep 03, 1996
SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM
K962616
Synthes (Usa)
Orthopedic · 62d
Cleared Jun 01, 1996
FOREFOOT RECONSTRUCTION SYSTEM
K961485
Howmedica Corp.
Orthopedic · 44d
Cleared Mar 22, 1996
SCHUHLI IMPLANT SYSTEM
K954963
Synthes (Usa)
Orthopedic · 144d
Cleared Mar 08, 1996
VOLAR DISTAL RADIUS PLATE
K953644
Synthes (Usa)
Orthopedic · 217d
Cleared Nov 20, 1995
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
K953714
Zimmer, Inc.
Orthopedic · 103d
Cleared Jun 22, 1995
LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW
K951415
Howmedica Corp.
Orthopedic · 86d
Cleared Jun 12, 1995
LUHR TITANIUM ALLOY PAN FIXATION SYSTEM
K945137
Howmedica Corp.
Orthopedic · 235d
Cleared Jun 12, 1995
LUHR TITANIUM PAN FIXATION SYSTEM
K945139
Howmedica Corp.
Orthopedic · 235d
Cleared May 16, 1995
ORTHOMET ACETABULAR ROOF REINFORCEMENT RING
K944856
Wrightmedicaltechnologyinc
Orthopedic · 225d
Cleared Apr 10, 1995
LUHR(R) TITANIUM ALLOY BURR HOLE COVERS
K950105
Howmedica Corp.
Orthopedic · 89d
Cleared Jan 20, 1995
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K943853
Wrightmedicaltechnologyinc
Orthopedic · 165d
Cleared Feb 23, 1994
LUHR MINI BONE SCREW AND Z PLATE
K935448
Howmedica Corp.
Orthopedic · 103d
Cleared Mar 04, 1993
LUHR PAN FIXATION SYSTEM
K923861
Howmedica Corp.
Orthopedic · 216d
Cleared Sep 22, 1992
DALL MILES BROAD BONE PLATE
K922525
Howmedica Corp.
Orthopedic · 117d
Cleared Jan 17, 1992
SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
K915818
Synthes (Usa)
Orthopedic · 18d
Cleared Dec 02, 1991
LUHR PAN FIXATION SYSTEM
K913355
Howmedica Corp.
Orthopedic · 126d