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
601–624 of 1322
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 Jun 30, 2014
MBD PLATE SYSTEM
K141045
Mbd Medical, LLC
Orthopedic · 68d
Cleared Jun 23, 2014
APTUS ULNA SHORTENING 2.5
K141232
Medartis AG
Orthopedic · 41d
Cleared Jun 20, 2014
AXSOS 3 TI LOCKING PLATE SYSTEM
K141121
Stryker Trauma AG
Orthopedic · 51d
Cleared Jun 20, 2014
VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM
K141204
Stryker Trauma AG
Orthopedic · 42d
Cleared Jun 13, 2014
ACUMED HAND FRACTURE SYSTEM
K141383
Acumed, LLC
Orthopedic · 17d
Cleared Jun 09, 2014
OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM
K140357
Orthopaedic Implant Company
Orthopedic · 117d
Cleared Jun 03, 2014
OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5
K140226
Science For Biomaterials
Orthopedic · 125d
Cleared May 29, 2014
VARIAX 2 COMPRESSION PLATING SYSTEM
K140565
Stryker Trauma AG
Orthopedic · 85d
Cleared May 22, 2014
SALVATION 3DI PLATING SYSTEM
K140792
Wrightmedicaltechnologyinc
Orthopedic · 52d
Cleared May 14, 2014
MSP METATARSAL SHORTENING SYSTEM
K140724
Nextremity Solutions, Inc.
Orthopedic · 54d
Cleared May 13, 2014
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
K140622
Biomet, Inc.
Orthopedic · 63d
Cleared May 08, 2014
AAP LOQTEC(R) OLECRANON PLATE
K140607
Aap Implantate AG
Orthopedic · 59d
Cleared May 07, 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814
Smith & Nephew, Inc.
Orthopedic · 36d
Cleared May 02, 2014
MATRIXRIB FIXATION SYSTEM
K133616
Synthes USA Products, LLC
Orthopedic · 158d
Cleared May 01, 2014
ORTHOPEDIC FIXATION SYSTEMS
K140216
Impact Medical, LLC
Orthopedic · 93d
Cleared Apr 25, 2014
PINIT SMALL BONE FUSION SYSTEM
K140617
Arthrosurface, Inc.
Orthopedic · 45d
Cleared Apr 17, 2014
PARALOCK PLATING SYSTEM / TUFFNEK SCREW
K140397
Paragon 28
Orthopedic · 58d
Cleared Apr 17, 2014
VARIAX 2 SYSTEM
K140769
Stryker Trauma AG
Orthopedic · 21d
Cleared Apr 07, 2014
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
K140069
Merete Medical GmbH
Orthopedic · 84d
Cleared Apr 07, 2014
FRAGMENT PLATE SYSTEM
K140372
Skeletal Dynamics, LLC
Orthopedic · 52d
Cleared Apr 03, 2014
VARIAX 2 SYSTEM
K140376
Stryker Trauma AG
Orthopedic · 48d