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
409–432 of 1311
Cleared Apr 07, 2017
ANTHEM™ Fracture System
K163361
Globus Medical, Inc.
Orthopedic · 128d
Cleared Mar 13, 2017
ORTHOLOC® 3Di Small Bones Plating
K163039
Wrightmedicaltechnologyinc
Orthopedic · 133d
Cleared Mar 09, 2017
Level One Hand Plating System
K170124
KLS-Martin L.P.
Orthopedic · 55d
Cleared Jan 26, 2017
ORTHOLOC® 3Di Ankle Fracture Plating System
K163044
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Dec 21, 2016
VLP MINI-MOD 2.0mm Column Plates
K163086
Smith & Nephew, Inc.
Orthopedic · 48d
Cleared Dec 09, 2016
Medline UNITE® Ankle Fracture Plating System
K162829
Medline Industries, Inc.
Orthopedic · 63d
Cleared Nov 18, 2016
EVOS Small Fragment Plating System
K162078
Smith & Nephew, Inc.
Orthopedic · 114d
Cleared Nov 15, 2016
VLP Wrist Fracture System
K161665
Smith & Nephew, Inc.
Orthopedic · 152d
Cleared Oct 12, 2016
Ulna Plating System
K162424
Biomet, Inc.
Orthopedic · 43d
Cleared May 17, 2016
BIOFOAM Bone Wedge
K152062
Wrightmedicaltechnologyinc
Orthopedic · 298d
Cleared Jan 28, 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716
Zimmer, Inc.
Orthopedic · 217d
Cleared Dec 11, 2015
ORTHOLOC® 3Di Foot Plating Reconstruction System
K152974
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Nov 12, 2015
VLP Mini-Mod Talus Plates
K152976
Smith & Nephew, Inc.
Orthopedic · 35d
Cleared Sep 04, 2015
TOTAL COMPRESSION PLATING (TCP) SYSTEM
K151442
Wrightmedicaltechnologyinc
Orthopedic · 98d
Cleared Aug 28, 2015
Arthrex Fracture Plates
K151732
Arthrex, Inc.
Orthopedic · 63d
Cleared Aug 06, 2015
Medline Foot Plates and Screws
K151235
Medline Industries, Inc.
Orthopedic · 87d
Cleared May 20, 2015
BIOFOAM Bone Wedge
K142724
Wrightmedicaltechnologyinc
Orthopedic · 239d
Cleared Apr 29, 2015
Arthrex Plates, Screws, and Staples
K150456
Arthrex, Inc.
Orthopedic · 68d
Cleared Apr 29, 2015
DARCO Locking Bone Plate System
K150520
Wrightmedicaltechnologyinc
Orthopedic · 58d
Cleared Apr 03, 2015
Arthrex Distal Radius System
K143749
Arthrex, Inc.
Orthopedic · 93d
Cleared Mar 30, 2015
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
K141527
Synthes (Usa)
Orthopedic · 294d
Cleared Mar 04, 2015
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
K143331
Zimmer, Inc.
Orthopedic · 104d
Cleared Feb 23, 2015
Zimmer Periarticular Plating System
K150121
Zimmer, Inc.
Orthopedic · 34d
Cleared Jan 16, 2015
Arthrex Fracture System
K143139
Arthrex, Inc.
Orthopedic · 74d