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
1129–1152 of 1333
Cleared May 08, 2002
SYNTHES CALCANEAL PLATE
K020401
Synthes (Usa)
Orthopedic · 90d
Cleared Apr 22, 2002
DISTAL RADIUS PLATING SYSTEM
K020819
Biomet, Inc.
Orthopedic · 40d
Cleared Apr 02, 2002
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET
K020221
Biomet Orthopedics, Inc.
Orthopedic · 70d
Cleared Mar 27, 2002
UNIVERSAL BONE PLATE III SYSTEM (UBP III)
K020611
Spinal Concepts, Inc.
Orthopedic · 30d
Cleared Mar 21, 2002
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE
K014197
Synthes (Usa)
Orthopedic · 90d
Cleared Mar 18, 2002
OPENING/CLOSING WEDGE OSTETOMY PLATES
K014155
Arthrex, Inc.
Orthopedic · 89d
Cleared Jan 11, 2002
SYNTHES ANKLE ARTHRODESIS PLATE
K013415
Synthes (Usa)
Orthopedic · 88d
Cleared Jan 08, 2002
TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
K013775
Stryker Leibinger
Orthopedic · 56d
Cleared Dec 20, 2001
LORENZ LACTOSORB PANELS AND FASTENERS
K011139
Biomet, Inc.
Orthopedic · 251d
Cleared Dec 19, 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248
Synthes (Usa)
Orthopedic · 82d
Cleared Dec 03, 2001
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
K013657
Biomet Orthopedics, Inc.
Orthopedic · 27d
Cleared Nov 07, 2001
CONGRUENT BONE PLATE SYSTEM
K012655
Acu Med, Inc.
Orthopedic · 86d
Cleared Sep 28, 2001
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
K012114
Synthes (Usa)
Orthopedic · 84d
Cleared Aug 31, 2001
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
K012162
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Aug 09, 2001
SYNTHES LCP PROXIMAL TIBIA PLATE
K011978
Synthes (Usa)
Orthopedic · 45d
Cleared Aug 07, 2001
WUJIN #3 FEMORAL BONE PLATE
K011459
Biopro, Inc.
Orthopedic · 88d
Cleared Aug 07, 2001
WUJIN #3 TIBIAL BONE PLATE
K011460
Biopro, Inc.
Orthopedic · 88d
Cleared Jul 31, 2001
HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
K011354
Dj Orthopedics, LLC
Orthopedic · 89d
Cleared Jul 27, 2001
SYNTHES CURVED RECONSTRUCTION PLATE
K011334
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 27, 2001
SYNTHS ONE-THIRD TUBULAR DCL PLATE
K011335
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 20, 2001
NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K011118
Osteomedics
Orthopedic · 99d
Cleared Jul 16, 2001
LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
K011076
Walter Lorenz Surgical, Inc.
Orthopedic · 98d
Cleared Jul 05, 2001
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
K011170
Synthes (Usa)
Orthopedic · 79d
Cleared May 30, 2001
SYNTHES RESORABLE MESHES AND SHEETS
K003788
Synthes (Usa)
Orthopedic · 173d