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
1009–1032 of 1333
Cleared May 19, 2006
AXSOS PLUS LOCKING PLATE SYSTEM
K061012
Howmedica Osteonics Corp.
Orthopedic · 37d
Cleared May 17, 2006
TTC PLATE
K060473
New Deal, S.A.
Orthopedic · 83d
Cleared May 17, 2006
LAPIDUS PLATE
K060476
New Deal, S.A.
Orthopedic · 83d
Cleared May 12, 2006
POLYAX LOCKED PLATING SYSTEM
K060969
DePuy Orthopaedics, Inc.
Orthopedic · 35d
Cleared Apr 12, 2006
STRYKER PLATING SYSTEM
K060798
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Mar 22, 2006
DIAPHYSEAL PLATE
K060294
Hand Innovations, LLC
Orthopedic · 44d
Cleared Mar 20, 2006
STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM
K060156
I.T.S. Implantat-Technologie-Systeme GmbH
Orthopedic · 59d
Cleared Mar 17, 2006
STRYKER PLATING SYSTEM
K060514
Howmedica Osteonics Corp.
Orthopedic · 18d
Cleared Feb 27, 2006
DRLOCK DISTAL RADIUS VOLAR SYSTEM
K053182
Orthohelix Surgical Designs, Inc.
Orthopedic · 105d
Cleared Feb 07, 2006
TRIMED BONE PLATES
K060041
TriMed, Inc.
Orthopedic · 32d
Cleared Dec 22, 2005
NEXA BONE PLATE AND SCREW SYSTEM
K053408
Nexa Orthopedics, Inc.
Orthopedic · 15d
Cleared Dec 12, 2005
ARTHREX TENSIONLOK
K052901
Arthrex, Inc.
Orthopedic · 59d
Cleared Dec 05, 2005
SYNTHES (USA) STERNAL FIXATION SYSTEM
K052683
Synthes (Usa)
Orthopedic · 68d
Cleared Nov 16, 2005
INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE
K052624
Inion , Ltd.
Orthopedic · 54d
Cleared Oct 25, 2005
COLLAGEN BONE HEALING PROTECTIVE SHEET
K052041
Collagen Matrix, Inc.
Orthopedic · 89d
Cleared Oct 21, 2005
SHOULDER NAIL PLATE
K052294
Hand Innovations, LLC
Orthopedic · 59d
Cleared Oct 17, 2005
OLECRANONPLATE WITH ANGULAR STABILITY
K052368
I.T.S. Implantat-Technologie-Systeme GmbH
Orthopedic · 49d
Cleared Oct 12, 2005
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)
K052677
Synthes (Usa)
Orthopedic · 14d
Cleared Oct 07, 2005
SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
K052390
Synthes (Usa)
Orthopedic · 37d
Cleared Oct 07, 2005
S-BONE HIP TOOL
K052538
Orthopedic Sciences, Inc.
Orthopedic · 22d
Cleared Sep 28, 2005
LOW PROFILE PLATE AND SCREW SYSTEM
K052614
Arthrex, Inc.
Orthopedic · 5d
Cleared Sep 14, 2005
DORSAL NAIL PLATE, ANATOMICAL
K052248
Hand Innovations, LLC
Orthopedic · 27d
Cleared Sep 13, 2005
B-BOP PLATE
K052152
New Deal, S.A.
Orthopedic · 36d
Cleared Sep 08, 2005
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
K051986
Synthes (Usa)
Orthopedic · 48d