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..

1311
Total
1311
Cleared
116d
Avg days
1976
Since
1311 devices
625–648 of 1311
Cleared Jul 27, 2001
SYNTHS ONE-THIRD TUBULAR DCL PLATE
K011335
Synthes (Usa)
Orthopedic · 86d
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 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 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
Cleared Dec 09, 1999
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
K993106
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Nov 16, 1999
MODIFIED BMP TROCHANTERIC PLATES
K993510
Biomet, Inc.
Orthopedic · 29d
Cleared Jul 30, 1999
LACTOSORB HAND SYSTEM
K991763
Biomet, Inc.
Orthopedic · 67d
Cleared Jan 21, 1999
SYNTHES PROXIMAL TIBIA PLATING SYSTEM
K983787
Synthes (Usa)
Orthopedic · 86d
Cleared Dec 16, 1998
PEDIATRIC CANNULATED OSTEOTOMY PLATES
K983967
Biomet, Inc.
Orthopedic · 40d
Cleared Nov 25, 1998
HOFFMANN II MIAMI POST
K983419
Howmedica Corp.
Orthopedic · 57d
Cleared Oct 16, 1998
HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
K982531
Howmedica Corp.
Orthopedic · 88d
Cleared Oct 13, 1998
MINI-FIXATOR FOR COLLES FRACTURES
K982982
Biomet, Inc.
Orthopedic · 48d
Cleared Jun 10, 1998
ARTHREX PUDDU OSTEOTOMY SYSTEM
K973812
Arthrex, Inc.
Orthopedic · 246d