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
Cleared
Sep 08, 2004
ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
Arthrex, Inc.
Orthopedic
49d
Cleared
Jul 01, 2004
ARTHREX SMALL FRAGMENT PLATES AND SCREWS
Arthrex, Inc.
Orthopedic
85d
Cleared
Jul 01, 2004
RADIAL NAIL SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
80d
Cleared
Jun 18, 2004
LCP RADIAL HEAD PLATING SYSTEM
Synthes (Usa)
Orthopedic
84d
Cleared
May 07, 2004
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
Synthes (Usa)
Orthopedic
63d
Cleared
Apr 12, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
Zimmer, Inc.
Orthopedic
35d
Cleared
Jan 28, 2004
EVOLVE RADIAL PLATE
Wrightmedicaltechnologyinc
Orthopedic
90d
Cleared
Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
Smith & Nephew, Inc.
Orthopedic
19d
Cleared
Dec 05, 2003
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
Biomet, Inc.
Orthopedic
28d
Cleared
Nov 18, 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
Arthrex, Inc.
Orthopedic
173d
Cleared
Oct 22, 2003
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
Synthes (Usa)
Orthopedic
64d
Cleared
Sep 22, 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
Arthrex, Inc.
Orthopedic
67d
Cleared
Sep 17, 2003
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
Synthes (Usa)
Orthopedic
56d
Cleared
Sep 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
Synthes (Usa)
Orthopedic
65d
Cleared
Aug 21, 2003
SYNTHES (USA) CALVICLE HOOK PLATE
Synthes (Usa)
Orthopedic
83d
Cleared
May 22, 2003
TEXAS T - PLATE
Biomet, Inc.
Orthopedic
24d
Cleared
May 05, 2003
SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES
Synthes (Usa)
Orthopedic
21d
Cleared
Apr 22, 2003
SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM
Synthes (Usa)
Orthopedic
82d
Cleared
Apr 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS
Synthes (Usa)
Orthopedic
17d
Cleared
Mar 20, 2003
SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES
Synthes (Usa)
Orthopedic
23d
Cleared
Feb 05, 2003
SMALL TITANIUM WRIST FUSION PLATE
Synthes (Usa)
Orthopedic
76d
Cleared
Jan 28, 2003
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
Synthes (Usa)
Orthopedic
75d
Cleared
Jul 25, 2002
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
Synthes (Usa)
Orthopedic
13d
Cleared
Jul 24, 2002
SYNTHES IN-SITU BENDER/CUTTER
Synthes (Usa)
Orthopedic
78d