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
745–768 of 1333
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
Cleared Mar 21, 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
K120070
Synthes (Usa)
Orthopedic · 72d
Cleared Mar 12, 2012
ADAPTIVE WEDGE
K110662
Adaptive Specialty, LLC
Orthopedic · 370d
Cleared Mar 12, 2012
TRAUMA INTERNAL FIXATION SYSTEMS
K111663
DePuy Orthopaedics, Inc.
Orthopedic · 272d
Cleared Mar 12, 2012
ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL
K112663
Enhatch Orthopaedics, LLC
Orthopedic · 181d
Cleared Feb 29, 2012
2.7MM LCP ULNA OSTEOTOMY SYSTEM
K113364
Synthes USA Products, LLC
Orthopedic · 106d
Cleared Feb 17, 2012
ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM
K120163
Acute Innovations, LLC
Orthopedic · 29d
Cleared Feb 07, 2012
ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
K111678
Ortho Solutions Limited
Orthopedic · 237d
Cleared Feb 06, 2012
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
K113762
Arthrosurface, Inc.
Orthopedic · 47d
Cleared Jan 31, 2012
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
K113014
Wrightmedicaltechnologyinc
Orthopedic · 112d
Cleared Jan 30, 2012
MAXLOCK EXTREME SYSTEM
K113048
Orthohelix Surgical Designs, Inc.
Orthopedic · 110d
Cleared Jan 27, 2012
NCB STRAIGHT NARROW SHAFT PLATES
K113718
Zimmer GmbH
Orthopedic · 39d
Cleared Jan 12, 2012
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
K113318
Acute Innovations, LLC
Orthopedic · 63d