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
1225–1248 of 1333
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 28, 1996
R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM
K961496
Howmedica, Inc.
Orthopedic · 71d
Cleared Jun 28, 1996
PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K961497
Howmedica, Inc.
Orthopedic · 71d
Cleared Jun 13, 1996
PLAMP, PLAMP PLATE, PLAMP WITH HOOK
K942032
Hospital For Special Surgery
Orthopedic · 779d
Cleared Jun 01, 1996
FOREFOOT RECONSTRUCTION SYSTEM
K961485
Howmedica Corp.
Orthopedic · 44d
Cleared Apr 10, 1996
LACTOSORB TRAUMA PLATING SYSTEM
K960988
Poly-Medics,Inc.
Orthopedic · 34d
Cleared Apr 01, 1996
ACE HUMERUS & RADIUS PLATES
K955472
Ace Medical Co.
Orthopedic · 123d
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 Feb 14, 1996
LACTOSORB TRAUMA PLATING SYSTEM
K955729
Poly-Medics,Inc.
Orthopedic · 58d
Cleared Dec 13, 1995
RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)
K952766
Creative Medical Designs, Inc.
Orthopedic · 196d
Cleared Nov 20, 1995
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
K953714
Zimmer, Inc.
Orthopedic · 103d
Cleared Jul 05, 1995
ORTHOPEDIC BONE PLATE
K932352
Osteomed Corp.
Orthopedic · 782d
Cleared Jul 05, 1995
LINK ENDO MODEL REVISION CUP
K943986
Turnkey Intergration USA, Inc.
Orthopedic · 323d
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 23, 1995
CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM
K946165
Elekta Instruments, Inc.
Orthopedic · 155d
Cleared May 16, 1995
ORTHOMET ACETABULAR ROOF REINFORCEMENT RING
K944856
Wrightmedicaltechnologyinc
Orthopedic · 225d
Cleared May 10, 1995
ACE SUPRACONDYLAR PLATE
K950618
Ace Medical Co.
Orthopedic · 89d
Cleared Apr 13, 1995
BONE PLATE SYSTEM
K942359
Acu Med, Inc.
Orthopedic · 331d
Cleared Apr 10, 1995
LUHR(R) TITANIUM ALLOY BURR HOLE COVERS
K950105
Howmedica Corp.
Orthopedic · 89d