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
889–912 of 1322
Cleared Mar 20, 2008
AAP BONE PLATES AND SCREW IMPLANTS
K072411
Aap Implantate AG
Orthopedic · 206d
Cleared Mar 20, 2008
MODULAR FOOT SYSTEM
K073624
Orthohelix Surgical Designs, Inc.
Orthopedic · 85d
Cleared Mar 19, 2008
VARIAX DISTAL RADIUS TORX SCREWS
K080667
Howmedica Osteonics Corp.
Orthopedic · 9d
Cleared Feb 29, 2008
DC ULNAR SHORTENING SYSTEM
K073228
Orthopro, LLC
Orthopedic · 106d
Cleared Feb 27, 2008
CHARLOTTE CLAW 3.5
K080295
Wrightmedicaltechnologyinc
Orthopedic · 23d
Cleared Feb 21, 2008
ENSPLINTRX BONE FIXATION SYSTEM
K071809
Sonoma Orthopedic Products, Inc.
Orthopedic · 234d
Cleared Feb 21, 2008
NEWDEAL TIBIAXYS SYSTEM
K073375
Newdeal Sas
Orthopedic · 80d
Cleared Feb 21, 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K073460
Synthes (Usa)
Orthopedic · 73d
Cleared Feb 19, 2008
ORTHOPEDIATRICS PLATING SYSTEM
K073344
Orthopediatrics, LLC
Orthopedic · 83d
Cleared Jan 07, 2008
BIOFOAM BONE WEDGE
K073535
Wrightmedicaltechnologyinc
Orthopedic · 21d
Cleared Dec 17, 2007
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K073186
Synthes (Usa)
Orthopedic · 34d
Cleared Dec 14, 2007
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
K072832
DePuy Orthopaedics, Inc.
Orthopedic · 72d
Cleared Nov 19, 2007
MONDEAL EXTREMITY BONE FIXATION SYSTEM
K072740
Mondeal Medical Systems GmbH
Orthopedic · 53d
Cleared Nov 19, 2007
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS
K072818
Smith & Nephew, Inc.
Orthopedic · 48d
Cleared Nov 07, 2007
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.
K072423
DePuy Orthopaedics, Inc.
Orthopedic · 70d
Cleared Oct 25, 2007
SMALL FRAGMENT LOCKING PLATING SYSTEM
K072083
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Oct 05, 2007
SMALL BONE WEDGE
K070592
Wrightmedicaltechnologyinc
Orthopedic · 217d
Cleared Sep 17, 2007
MONDEAL HAND CONTOUR SYSTEM
K071797
Mondeal Medical Systems GmbH
Orthopedic · 77d
Cleared Sep 17, 2007
MONDEAL DISTAL RADIUS SYSTEM
K071798
Mondeal Medical Systems GmbH
Orthopedic · 77d
Cleared Sep 06, 2007
BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
K071577
Biomet Microfixation, Inc.
Orthopedic · 90d
Cleared Aug 21, 2007
TITANIUM HIP TOOL LOCKING PLATE
K072175
Orthopedic Sciences, Inc.
Orthopedic · 15d
Cleared Aug 08, 2007
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K071563
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Aug 07, 2007
SBI RHEAD PLATING SYSTEM
K071549
Small Bone Innovations, Inc.
Orthopedic · 62d
Cleared Jul 30, 2007
OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM
K071105
Osteomed LP
Orthopedic · 102d