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
1177–1200 of 1333
Cleared Mar 17, 1999
ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
K990481
Biodynamic Technologies, Inc.
Orthopedic · 29d
Cleared Feb 18, 1999
KMI WRIST FUSION SYSTEM
K990094
Kinetikos Medical, Inc.
Orthopedic · 37d
Cleared Jan 27, 1999
SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE
K983988
Syntec Scientific Corp.
Orthopedic · 79d
Cleared Jan 21, 1999
SYNTHES PROXIMAL TIBIA PLATING SYSTEM
K983787
Synthes (Usa)
Orthopedic · 86d
Cleared Dec 31, 1998
DEPUY ACE SPIDER PLATE
K984458
Depuy Ace Medical Co.
Orthopedic · 16d
Cleared Dec 22, 1998
DEPUY ACE TIMAX META PLATE
K983853
Depuy Ace Medical Co.
Orthopedic · 53d
Cleared Dec 16, 1998
PEDIATRIC CANNULATED OSTEOTOMY PLATES
K983967
Biomet, Inc.
Orthopedic · 40d
Cleared Dec 04, 1998
COBRA EXTERNAL FIXATOR
K983881
Orthopaedic Innovations, Inc.
Orthopedic · 32d
Cleared Nov 25, 1998
HOFFMANN II MIAMI POST
K983419
Howmedica Corp.
Orthopedic · 57d
Cleared Oct 16, 1998
HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
K982531
Howmedica Corp.
Orthopedic · 88d
Cleared Oct 13, 1998
MINI-FIXATOR FOR COLLES FRACTURES
K982982
Biomet, Inc.
Orthopedic · 48d
Cleared Oct 08, 1998
SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)
K982732
Synthes
Orthopedic · 64d
Cleared Sep 22, 1998
OSTEO COMPRESSION HIP SCREW SYSTEM
K982553
Osteonics Corp.
Orthopedic · 62d
Cleared Sep 14, 1998
DEPUY MOTECH PEAK FIXATION SYSTEM
K982483
DePuy Orthopaedics, Inc.
Orthopedic · 59d
Cleared Aug 31, 1998
DEPUY ACE TIMAX PILON PLATE
K982347
Depuy Ace Medical Co.
Orthopedic · 56d
Cleared Jul 30, 1998
MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)
K972913
Pacific Materials and Interfaces
Orthopedic · 357d
Cleared Jul 29, 1998
DISTAL RADIUS FRACTURE FIXATION PLATE
K981715
Avanta Orthopaedics, Inc.
Orthopedic · 75d
Cleared Jul 29, 1998
DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE
K981775
Depuy Ace Medical Co.
Orthopedic · 70d
Cleared Jul 13, 1998
LORENZ PECTUS SUPPORT BAR STABILIZER
K981789
Walter Lorenz Surgical, Inc.
Orthopedic · 54d
Cleared Jun 10, 1998
ARTHREX PUDDU OSTEOTOMY SYSTEM
K973812
Arthrex, Inc.
Orthopedic · 246d
Cleared Jun 10, 1998
ROGACHEFSKY DISTAL RADIUS PLATES
K981283
Howmedica, Inc.
Orthopedic · 63d
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 Mar 10, 1998
PLAQUAGRAFE, AGRAFE P4V
K974603
Atlas Technology
Orthopedic · 90d