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
985–1008 of 1322
Cleared Sep 13, 2005
B-BOP PLATE
K052152
New Deal, S.A.
Orthopedic · 36d
Cleared Sep 08, 2005
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
K051986
Synthes (Usa)
Orthopedic · 48d
Cleared Sep 08, 2005
VOLAR PLATE SYSTEM
K052150
Dvo Extremity Solutions, LLC
Orthopedic · 31d
Cleared Sep 06, 2005
SBI WRISTFIT
K051747
Small Bone Innovations, LLC
Orthopedic · 69d
Cleared Sep 06, 2005
MIOT PLATING SYSTEM
K051945
Orthofix Srl
Orthopedic · 50d
Cleared Aug 23, 2005
APTUS TITANIUM OSTEOSYNTHESIS SYSTEM
K051567
Medartis, Inc.
Orthopedic · 70d
Cleared Aug 10, 2005
CHARLOTTE COMPRESSION PLATE
K051908
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Aug 10, 2005
PILONPLATE WITH ANGULAR STABILITY
K052011
I.T.S. Implantat-Technologie-Systeme GmbH
Orthopedic · 16d
Cleared Aug 08, 2005
MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005
K050655
Kapp Surgical Instrument, Inc.
Orthopedic · 147d
Cleared Aug 08, 2005
MONDEAL CONTOUR HO SYSTEM
K050657
Kapp Surgical Instrument, Inc.
Orthopedic · 147d
Cleared Aug 05, 2005
CHARLOTTE SMALL MTP FUSION PLATE
K051884
Wrightmedicaltechnologyinc
Orthopedic · 24d
Cleared Jul 27, 2005
OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
K050681
TriMed, Inc.
Orthopedic · 133d
Cleared Jul 21, 2005
ACUMED RIB CONGRIENT BONE PLATE SYSTEM
K051410
Acumed, LLC
Orthopedic · 51d
Cleared Jul 19, 2005
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY
K051735
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jul 11, 2005
SOLCO 4CIS GENERAL PLATE SYSTEM
K051155
Solco Biomedical Co., Ltd.
Orthopedic · 68d
Cleared Jul 11, 2005
HUMERAL HEAD PLATE WITH ANGULAR STABILITY
K051412
I.T.S. Implantat-Technologie-Systeme GmbH
Orthopedic · 41d
Cleared Jun 22, 2005
CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM
K050852
I.T.S. Implantat-Technologie-Systeme GmbH
Orthopedic · 79d
Cleared May 27, 2005
MAXLOCK
K050868
Orthohelix Surgical Designs, Inc.
Orthopedic · 51d
Cleared May 23, 2005
TITANIUM-HIP TOOL
K051032
Orthopedic Sciences, Inc.
Orthopedic · 31d
Cleared May 23, 2005
CUSTOM-HIP TOOL
K051181
Orthopedic Sciences, Inc.
Orthopedic · 14d
Cleared May 12, 2005
ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
K051083
Acumed, LLC
Orthopedic · 15d
Cleared Apr 26, 2005
SBI HAND FIXATION SYSTEM (TM)
K050462
Small Bone Innovations, LLC
Orthopedic · 62d
Cleared Apr 26, 2005
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K050646
Synthes (Usa)
Orthopedic · 43d
Cleared Apr 15, 2005
THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10
K050101
Zimmer Trabecular
Orthopedic · 87d