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
721–744 of 1322
Cleared Sep 06, 2012
MAXLOCK EXTREME SYSTEM
K122005
Orthohelix Surgical Designs, Inc.
Orthopedic · 59d
Cleared Aug 30, 2012
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T
K113652
Aap Implantate AG
Orthopedic · 262d
Cleared Aug 20, 2012
GRIDLOCK PLATING SYSTEM
K121452
Trilliant Surgical, Ltd.
Orthopedic · 96d
Cleared Jul 26, 2012
PIONEER STERNAL ASSIST IMPLANT SYSTEM
K120016
Pioneer Surgical Technology, Inc.
Orthopedic · 205d
Cleared Jul 13, 2012
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
K120903
Acumed, LLC
Orthopedic · 109d
Cleared Jul 06, 2012
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
K121601
Synthes (Usa)
Orthopedic · 35d
Cleared Jun 18, 2012
SYNTHES VA LCP ANKLE TRAUMA SYSTEM
K120854
Synthes (Usa)
Orthopedic · 89d
Cleared Jun 13, 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
K121437
Orthohelix Surgical Designs, Inc.
Orthopedic · 29d
Cleared Jun 12, 2012
NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
K120772
Zimmer GmbH
Orthopedic · 90d
Cleared Jun 04, 2012
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
K120689
Synthes USA Products, LLC
Orthopedic · 90d
Cleared May 29, 2012
ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
K120360
Ortho Solutions Limited
Orthopedic · 113d
Cleared May 10, 2012
EOS SMALL BONE FIXATION SYSTEM
K112794
TriMed, Inc.
Orthopedic · 227d
Cleared May 08, 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
K120717
Synthes (Usa)
Orthopedic · 61d
Cleared May 03, 2012
ORTHOLOC 3DI HALLUX SYSTEM
K120359
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared May 02, 2012
MICROWARE BONE PLATES AND BONE SCREW
K111008
Microware Precision Co., Ltd.
Orthopedic · 387d
Cleared Apr 27, 2012
APTUS PROXIMAL HUMERUS SYSTEM
K120108
Medartis AG
Orthopedic · 105d
Cleared Apr 25, 2012
VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK
K113760
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 126d
Cleared Apr 24, 2012
OSTEOMED WRIST PLATING SYSTEM
K120015
Osteomed LP
Orthopedic · 112d
Cleared Apr 19, 2012
OTIS-C PLUS
K120818
Science For Biomaterials
Orthopedic · 31d
Cleared Apr 10, 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
K120157
Orthohelix Surgical Designs, Inc.
Orthopedic · 83d
Cleared Apr 04, 2012
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT
K120667
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Apr 02, 2012
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS
K120802
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Mar 29, 2012
LOCKING COMPRESSION PLATE SYSTEM
K112798
Shanghai Microport Orthopedics Co., Ltd.
Orthopedic · 184d
Cleared Mar 23, 2012
SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX
K113733
Neoortho Produtos Ortopedicos S/A
Orthopedic · 95d