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
793–816 of 1322
Cleared Mar 18, 2011
AXSOS (TM) LOCKING PLATE SYSTEM
K110476
Stryker Corp.
Orthopedic · 28d
Cleared Feb 15, 2011
AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS
K110176
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 25d
Cleared Jan 24, 2011
APTUS ULNA PLATES
K103332
Medartis AG
Orthopedic · 73d
Cleared Jan 21, 2011
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
K103243
Synthes (Usa)
Orthopedic · 81d
Cleared Jan 04, 2011
CONGRUENT BONE PLATE SYSTEM
K102998
Acumed, LLC
Orthopedic · 88d
Cleared Dec 16, 2010
POSTERIOR LATERAL PLATES
K103408
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Dec 15, 2010
CONTOURS LAPIDUS PLATING SYSTEM
K102201
Orthofix, Inc.
Orthopedic · 133d
Cleared Dec 10, 2010
APTUS 1.5 TRILOCK
K102537
Medartis AG
Orthopedic · 98d
Cleared Dec 09, 2010
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
K102694
Synthes (Usa)
Orthopedic · 80d
Cleared Dec 07, 2010
THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES
K102282
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 117d
Cleared Dec 02, 2010
EVOLVE EPS ORTHOLOC
K102352
Wrightmedicaltechnologyinc
Orthopedic · 105d
Cleared Nov 24, 2010
HTO PLATING SYSTEM
K102505
Aesculap Implant Systems, LLC
Orthopedic · 84d
Cleared Nov 23, 2010
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
K102429
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Oct 22, 2010
CLAVICLE LOCKING PLATE SYSTEM
K100944
Newclip Technics
Orthopedic · 199d
Cleared Oct 20, 2010
CONTOURS VSP III VOLAR PLATING SYSTEM
K101936
Orthofix, Inc.
Orthopedic · 100d
Cleared Oct 06, 2010
ACUMED WRIST ARTHRODESIS PLATE SYSTEM
K100123
Acumed, LLC
Orthopedic · 264d
Cleared Sep 30, 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
K102156
Orthohelix Surgical Designs, Inc.
Orthopedic · 62d
Cleared Sep 27, 2010
MINI MAXLOCK EXTREME PLATING SYSTEM
K101962
Orthohelix Surgical Designs, Inc.
Orthopedic · 76d
Cleared Aug 03, 2010
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K100776
Synthes (Usa)
Orthopedic · 138d
Cleared Aug 02, 2010
ASCENSION TOTAL PLATE SYSTEM
K100502
Ascension Orthopedics, Inc.
Orthopedic · 161d
Cleared Jul 23, 2010
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22
K101240
DePuy Orthopaedics, Inc.
Orthopedic · 80d
Cleared Jun 16, 2010
ASCENSION ANKLE FUSION PLATE SYSTEM
K100176
Ascension Orthopedics, Inc.
Orthopedic · 146d
Cleared Jun 15, 2010
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708
K101421
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared May 17, 2010
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
K100240
OrthoPediatrics Corp.
Orthopedic · 110d