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
865–888 of 1322
Cleared Jan 30, 2009
ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM
K083286
OrthoPediatrics Corp.
Orthopedic · 86d
Cleared Jan 14, 2009
SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
K083025
Synthes (Usa)
Orthopedic · 96d
Cleared Jan 07, 2009
PERI-LOC BONE PLATING AND SCREW SYSTEM
K083032
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Dec 30, 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K083213
Synthes (Usa)
Orthopedic · 60d
Cleared Dec 18, 2008
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS
K082527
Zimmer, Inc.
Orthopedic · 107d
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 Aug 26, 2008
SMALL BONE LOCKING PLATING SYSTEM
K081546
DePuy Orthopaedics, Inc.
Orthopedic · 85d
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 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 20, 2008
AAP BONE PLATES AND SCREW IMPLANTS
K072411
Aap Implantate AG
Orthopedic · 206d