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
577–600 of 1311
Cleared Sep 08, 2004
ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
K041965
Arthrex, Inc.
Orthopedic · 49d
Cleared Jul 01, 2004
ARTHREX SMALL FRAGMENT PLATES AND SCREWS
K040907
Arthrex, Inc.
Orthopedic · 85d
Cleared Jul 01, 2004
RADIAL NAIL SYSTEM
K040938
Wrightmedicaltechnologyinc
Orthopedic · 80d
Cleared Jun 18, 2004
LCP RADIAL HEAD PLATING SYSTEM
K040777
Synthes (Usa)
Orthopedic · 84d
Cleared May 07, 2004
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
K040588
Synthes (Usa)
Orthopedic · 63d
Cleared Apr 12, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
K040593
Zimmer, Inc.
Orthopedic · 35d
Cleared Jan 28, 2004
EVOLVE RADIAL PLATE
K033456
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Dec 05, 2003
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K033519
Biomet, Inc.
Orthopedic · 28d
Cleared Nov 18, 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
K031666
Arthrex, Inc.
Orthopedic · 173d
Cleared Oct 22, 2003
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
K032559
Synthes (Usa)
Orthopedic · 64d
Cleared Sep 22, 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
K032187
Arthrex, Inc.
Orthopedic · 67d
Cleared Sep 17, 2003
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K032269
Synthes (Usa)
Orthopedic · 56d
Cleared Sep 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
K032032
Synthes (Usa)
Orthopedic · 65d
Cleared Aug 21, 2003
SYNTHES (USA) CALVICLE HOOK PLATE
K031677
Synthes (Usa)
Orthopedic · 83d
Cleared May 22, 2003
TEXAS T - PLATE
K031334
Biomet, Inc.
Orthopedic · 24d
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 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 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