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
1081–1104 of 1333
Cleared Jun 24, 2004
TSY SHOULDER PLATE IMPLANT
K040850
Orthopedic Sciences, Inc.
Orthopedic · 85d
Cleared Jun 18, 2004
LCP RADIAL HEAD PLATING SYSTEM
K040777
Synthes (Usa)
Orthopedic · 84d
Cleared Jun 17, 2004
INTEGRA BONE FIXATION SYSTEM
K040860
Integra LifeSciences Corporation
Orthopedic · 76d
Cleared May 13, 2004
KLS MARTIN HAND PLATING SYSTEM
K040598
KLS-Martin L.P.
Orthopedic · 66d
Cleared May 07, 2004
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
K040588
Synthes (Usa)
Orthopedic · 63d
Cleared Apr 12, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
K040593
Zimmer, Inc.
Orthopedic · 35d
Cleared Mar 12, 2004
STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM
K040022
Stryker Leibinger
Orthopedic · 65d
Cleared Mar 12, 2004
TRIMED BEARING PLATE
K040112
Tri-Med, Inc.
Orthopedic · 52d
Cleared Mar 01, 2004
INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
K031961
Inion , Ltd.
Orthopedic · 250d
Cleared Feb 06, 2004
VOLAR RADIUS PLATE WITH ANGULAR STABILITY
K033756
I.T.S. Implantat-Technologie-Systeme GmbH
Orthopedic · 67d
Cleared Feb 05, 2004
TRIMED RADIAL BULLET
K030877
Tri-Med, Inc.
Orthopedic · 322d
Cleared Jan 28, 2004
EVOLVE RADIAL PLATE
K033456
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Dec 05, 2003
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K033519
Biomet, Inc.
Orthopedic · 28d
Cleared Nov 20, 2003
GROWTH GUIDANCE PLATE
K031493
University of Utah/School of Medicine
Orthopedic · 192d
Cleared Nov 18, 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
K031666
Arthrex, Inc.
Orthopedic · 173d
Cleared Oct 22, 2003
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
K032559
Synthes (Usa)
Orthopedic · 64d
Cleared Oct 10, 2003
KLS-MARTIN STERNAL PLATING SYSTEM
K032413
KLS-Martin L.P.
Orthopedic · 66d
Cleared Sep 22, 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
K032187
Arthrex, Inc.
Orthopedic · 67d
Cleared Sep 17, 2003
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K032269
Synthes (Usa)
Orthopedic · 56d
Cleared Sep 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
K032032
Synthes (Usa)
Orthopedic · 65d
Cleared Aug 21, 2003
SYNTHES (USA) CALVICLE HOOK PLATE
K031677
Synthes (Usa)
Orthopedic · 83d
Cleared Jun 09, 2003
SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM
K031609
Swiss Orthopedic Solutions, Inc.
Orthopedic · 18d
Cleared May 22, 2003
TEXAS T - PLATE
K031334
Biomet, Inc.
Orthopedic · 24d