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
937–960 of 1322
Cleared Dec 18, 2006
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
K063049
Synthes (Usa)
Orthopedic · 75d
Cleared Dec 18, 2006
LORENZ STERNAL CLOSURE SYSTEM
K063506
Walter Lorenz Surgical, Inc.
Orthopedic · 28d
Cleared Dec 14, 2006
INTAI BONE PLATE AND BONE SCREW SYSTEM
K063020
Intai Technology, Inc.
Orthopedic · 73d
Cleared Dec 07, 2006
ACUMED CONGRUENT BONE PLATE SYSTEM
K063460
Acumed, LLC
Orthopedic · 22d
Cleared Nov 22, 2006
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
K063303
Zimmer, Inc.
Orthopedic · 21d
Cleared Nov 01, 2006
MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT
K063033
Orthopedic Sciences, Inc.
Orthopedic · 29d
Cleared Oct 25, 2006
PROFYLE SYSTEM
K062498
Howmedica Osteonics Corp.
Orthopedic · 61d
Cleared Oct 20, 2006
SBI CARPAL FUSION PLATE
K062903
Small Bone Innovations, Inc.
Orthopedic · 23d
Cleared Oct 19, 2006
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
K062494
Ebi, L.P.
Orthopedic · 55d
Cleared Oct 19, 2006
SYNTHES LCP DISTAL FEMUR PLATES
K062564
Synthes (Usa)
Orthopedic · 49d
Cleared Sep 29, 2006
ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM
K062747
Arthrex, Inc.
Orthopedic · 15d
Cleared Sep 15, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K062216
Smith & Nephew, Inc.
Orthopedic · 45d
Cleared Sep 11, 2006
SYNTHES 3.5MM SPRING PLATE
K061973
Synthes (Usa)
Orthopedic · 61d
Cleared Sep 08, 2006
SYNTHES LCP ANKLE ARTHRODESIS PLATES
K061940
Synthes (Usa)
Orthopedic · 60d
Cleared Sep 07, 2006
KLS MARTIN STERNAL TALON
K051165
KLS-Martin L.P.
Orthopedic · 490d
Cleared Aug 28, 2006
DISTAL RADIUS LOCKING PLATING SYSTEM
K061917
Newclip Technics
Orthopedic · 53d
Cleared Aug 17, 2006
DARCO LOCKING BONE PLATE SYSTEM
K061808
Darco International, Inc.
Orthopedic · 51d
Cleared Aug 04, 2006
SYNTHES (USA) CLAVICLE HOOK PLATES
K061753
Synthes (Usa)
Orthopedic · 44d
Cleared Aug 04, 2006
RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS
K061955
Creative Medical Designs, Inc.
Orthopedic · 24d
Cleared Aug 03, 2006
LISFRANC PLATE
K060474
New Deal, S.A.
Orthopedic · 161d
Cleared Jul 17, 2006
MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
K053624
Medicon EG
Orthopedic · 201d
Cleared Jun 29, 2006
CALCANEAL TRAUMA SYSTEM
K061400
Orthohelix Surgical Designs, Inc.
Orthopedic · 41d
Cleared Jun 14, 2006
NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
K061211
Zimmer GmbH
Orthopedic · 44d
Cleared Jun 08, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY
K061352
Smith & Nephew, Inc.
Orthopedic · 24d