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
913–936 of 1333
Cleared Dec 17, 2008
SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
K082625
Synthes (Usa)
Orthopedic · 99d
Cleared Dec 11, 2008
2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424
K083364
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Dec 04, 2008
MICROWARE BONE PLATES AND BONE SCREWS
K072562
Microware Precision Co., Ltd.
Orthopedic · 450d
Cleared Nov 24, 2008
SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS
K082807
Synthes (Usa)
Orthopedic · 61d
Cleared Nov 10, 2008
SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES
K082624
Synthes (Usa)
Orthopedic · 62d
Cleared Nov 07, 2008
SYNTHES (USA) 3.5MM LCP HOOK PLATE
K082072
Synthes (Usa)
Orthopedic · 108d
Cleared Nov 03, 2008
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES
K082078
Zimmer, Inc.
Orthopedic · 103d
Cleared Oct 16, 2008
NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V
K081759
Zimmer GmbH
Orthopedic · 118d
Cleared Sep 09, 2008
CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
K081374
Wrightmedicaltechnologyinc
Orthopedic · 116d
Cleared Sep 08, 2008
SYNTHES RIB FIXATION SYSTEM
K081623
Synthes (Usa)
Orthopedic · 90d
Cleared Sep 04, 2008
AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
K080992
Aesculap Implant Systems, Inc.
Orthopedic · 150d
Cleared Sep 03, 2008
RE-ZORB PLATING SYSTEM
K081588
Acute Innovations, LLC
Orthopedic · 90d
Cleared Aug 26, 2008
SMALL BONE LOCKING PLATING SYSTEM
K081546
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Aug 13, 2008
TRAUSON BONE PLATE
K073432
Trauson (Jiangsu) Medical Instrument Co., Ltd.
Orthopedic · 251d
Cleared Jul 23, 2008
SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES
K081353
Synthes (Usa)
Orthopedic · 70d
Cleared Jul 22, 2008
ORTHOPEDIATRICS PEDIPLATES SYSTEM
K081407
OrthoPediatrics Corp.
Orthopedic · 64d
Cleared Jul 15, 2008
ORTHOMESH
K073115
Synthes (Usa)
Orthopedic · 253d
Cleared Jul 03, 2008
EVOLVE EPS SYSTEM
K081373
Wrightmedicaltechnologyinc
Orthopedic · 48d
Cleared Jun 24, 2008
MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
K073556
Medxpert GmbH
Orthopedic · 188d
Cleared Jun 18, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139
K081106
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared May 23, 2008
SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES
K080522
Synthes (Usa)
Orthopedic · 87d
Cleared Mar 26, 2008
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
K080184
I.T.S. Implantat-Technologie-Systeme GmbH
Orthopedic · 61d
Cleared Mar 20, 2008
AAP BONE PLATES AND SCREW IMPLANTS
K072411
Aap Implantate AG
Orthopedic · 206d
Cleared Mar 20, 2008
MODULAR FOOT SYSTEM
K073624
Orthohelix Surgical Designs, Inc.
Orthopedic · 85d