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
433–456 of 1311
Cleared Dec 18, 2014
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Dec 05, 2014
TOTAL COMPRESSION PLATING SYSTEM
K143025
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared Nov 28, 2014
Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers
K143066
Zimmer, Inc.
Orthopedic · 35d
Cleared Nov 12, 2014
Zimmer Plates and Screws (ZPS), Forte Screws
K142836
Zimmer, Inc.
Orthopedic · 43d
Cleared Oct 22, 2014
Zimmer Periarticular Plating System
K142579
Zimmer, Inc.
Orthopedic · 37d
Cleared Aug 21, 2014
VALOR HINDFOOT FUSION NAIL SYSTEM
K142121
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Aug 15, 2014
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735
Arthrex, Inc.
Orthopedic · 49d
Cleared Aug 14, 2014
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
K140508
Zimmer, Inc.
Orthopedic · 167d
Cleared Aug 13, 2014
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
K141517
Zimmer, Inc.
Orthopedic · 65d
Cleared Aug 13, 2014
ZIMMER PERIARTICULAR LOCKING SYSTEM
K141734
Zimmer, Inc.
Orthopedic · 47d
Cleared Jul 09, 2014
BIOFOAM BONE WEDGE
K140531
Wrightmedicaltechnologyinc
Orthopedic · 127d
Cleared Jul 09, 2014
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
K141417
Wrightmedicaltechnologyinc
Orthopedic · 41d
Cleared Jul 08, 2014
ARTHREX FRACTURE PLATES AND SCREWS
K141478
Arthrex, Inc.
Orthopedic · 34d
Cleared May 22, 2014
SALVATION 3DI PLATING SYSTEM
K140792
Wrightmedicaltechnologyinc
Orthopedic · 52d
Cleared May 13, 2014
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
K140622
Biomet, Inc.
Orthopedic · 63d
Cleared May 07, 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814
Smith & Nephew, Inc.
Orthopedic · 36d
Cleared Feb 28, 2014
CHARLOTTE CLAW PLATE SYSTEM
K133715
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Feb 04, 2014
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
K132886
Smith & Nephew, Inc.
Orthopedic · 141d
Cleared Jan 07, 2014
D-RAD SMART PACK
K132296
Smith & Nephew, Inc.
Orthopedic · 168d
Cleared Dec 17, 2013
ZIMMER DISTAL RADIUS PLATING SYSTEM
K133246
Zimmer, Inc.
Orthopedic · 56d
Cleared Oct 29, 2013
2.5MM INLINE FUSION PLATE
K131867
Biomet, Inc.
Orthopedic · 127d
Cleared Sep 25, 2013
ARTHREX COMPRESSION PLATES
K130510
Arthrex, Inc.
Orthopedic · 210d
Cleared Jul 03, 2013
ARTHREX DISTAL RADIUS PLATE SYSTEM
K131474
Arthrex, Inc.
Orthopedic · 42d
Cleared Jul 03, 2013
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
K131670
Biomet, Inc.
Orthopedic · 26d