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
1081–1104 of 1322
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 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 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
Cleared May 23, 2001
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
K011237
Biomet, Inc.
Orthopedic · 30d
Cleared Nov 06, 2000
PE.R.I. II KNEE FRACTURE SYSTEM
K003235
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Oct 31, 2000
SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM
K002361
Synthes (Usa)
Orthopedic · 89d
Cleared Sep 29, 2000
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)
K002710
Synthes (Usa)
Orthopedic · 29d
Cleared Sep 22, 2000
SYNTHES MODULAR FOOT SYSTEM
K001941
Synthes (Usa)
Orthopedic · 88d
Cleared Sep 22, 2000
SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES
K001945
Synthes (Usa)
Orthopedic · 88d
Cleared Aug 07, 2000
LACTOSORB PANELS AND FASTENERS
K984390
Biomet, Inc.
Orthopedic · 608d
Cleared Jul 24, 2000
MACROSORBOS PROTECTIVE SHEET
K994158
Macropore Biosurgery, Inc.
Orthopedic · 228d
Cleared Jun 20, 2000
SYNTHES (USA) ORIBITAL MESH PLATES
K001311
Synthes (Usa)
Orthopedic · 56d
Cleared May 11, 2000
STRYKER TRAUMA PLATING SYSTEM
K000636
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared Mar 15, 2000
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
K000066
Synthes (Usa)
Orthopedic · 65d
Cleared Feb 14, 2000
LOCON-T DISTAL RADIAL PLATE
K994061
Wrightmedicaltechnologyinc
Orthopedic · 75d
Cleared Jan 11, 2000
DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE
K993465
Depuy, Inc.
Orthopedic · 90d
Cleared Dec 20, 1999
LACTOSORB TRAUMA PLATING SYSTEM
K992355
Biomet, Inc.
Orthopedic · 159d