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..

1311
Total
1311
Cleared
116d
Avg days
1976
Since
1311 devices
505–528 of 1311
Cleared Jun 04, 2009
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
K090675
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared May 08, 2009
ORTHOLOC 2.0/2.4 PLATE SYSTEM
K090692
Wrightmedicaltechnologyinc
Orthopedic · 53d
Cleared Apr 01, 2009
SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM
K090047
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 06, 2009
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
K083694
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 04, 2009
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
K083573
Synthes (Usa)
Orthopedic · 91d
Cleared Feb 26, 2009
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)
K083654
Zimmer, Inc.
Orthopedic · 78d
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 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 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 Jul 23, 2008
SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES
K081353
Synthes (Usa)
Orthopedic · 70d
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 19, 2008
VARIAX DISTAL RADIUS TORX SCREWS
K080667
Howmedica Osteonics Corp.
Orthopedic · 9d
Cleared Feb 27, 2008
CHARLOTTE CLAW 3.5
K080295
Wrightmedicaltechnologyinc
Orthopedic · 23d