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..

1322
Total
1322
Cleared
116d
Avg days
1976
Since
1322 devices
1057–1080 of 1322
Cleared Apr 10, 2003
AVANTA CARPAL FUSION PLATING SYSTEM
K030881
Avanta Orthopaedics, Inc.
Orthopedic · 21d
Cleared Apr 10, 2003
AAP ACROPLATE
K030909
Aap Implantate AG
Orthopedic · 17d
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 Sep 17, 2002
BIOMET CALCANEAL PLATE
K022515
Biomet Orthopedics, Inc.
Orthopedic · 49d
Cleared Aug 12, 2002
HALLU PLATES
K021626
New Deal, S.A.
Orthopedic · 87d
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 Jul 17, 2002
WRIST FUSION PLATE
K021321
Acu Med, Inc.
Orthopedic · 83d
Cleared Jul 01, 2002
MACROPORE OS TRAUMA
K021164
Macropore Biosurgery, Inc.
Orthopedic · 81d
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 Apr 02, 2002
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET
K020221
Biomet Orthopedics, Inc.
Orthopedic · 70d
Cleared Mar 27, 2002
UNIVERSAL BONE PLATE III SYSTEM (UBP III)
K020611
Spinal Concepts, Inc.
Orthopedic · 30d
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 Dec 03, 2001
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
K013657
Biomet Orthopedics, Inc.
Orthopedic · 27d
Cleared Nov 07, 2001
CONGRUENT BONE PLATE SYSTEM
K012655
Acu Med, Inc.
Orthopedic · 86d