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
1105–1128 of 1333
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 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 Apr 01, 2003
HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM
K030198
Hand Innovations, Inc.
Orthopedic · 70d
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 Dec 05, 2002
DISTAL RADIUS FRACTURE REPAIR SYSTEM
K023007
Hand Innovations, Inc.
Orthopedic · 87d
Cleared Sep 23, 2002
HIP TOOL IMPLANT
K022139
Orthopedic Sciences, Inc.
Orthopedic · 83d
Cleared Sep 17, 2002
NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
K022324
Osteomedics, Inc.
Orthopedic · 62d
Cleared Sep 17, 2002
BIOMET CALCANEAL PLATE
K022515
Biomet Orthopedics, Inc.
Orthopedic · 49d
Cleared Sep 13, 2002
NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
K022231
Osteomedics, Inc.
Orthopedic · 65d
Cleared Sep 10, 2002
NORMED MINI EXTERNAL FIXATOR SYSTEM
K022230
Osteomedics, Inc.
Orthopedic · 62d
Cleared Sep 09, 2002
NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
K022323
Osteomedics, Inc.
Orthopedic · 54d
Cleared Sep 09, 2002
NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
K022325
Osteomedics, Inc.
Orthopedic · 54d
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 20, 2002
SYNTHES PILON PLATE
K020602
Synthes
Orthopedic · 87d