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..

1319
Total
1319
Cleared
116d
Avg days
1976
Since
1319 devices
481–504 of 1319
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 Aug 07, 2014
MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM
K141241
Synthes USA Products, LLC
Orthopedic · 86d
Cleared Aug 07, 2014
AAP LOQTEC CLAVICLE PLATES 2.7/3.5
K141823
Aap Implantate AG
Orthopedic · 31d
Cleared Jul 29, 2014
PEDILOC FRAGMENT SYSTEM
K140431
OrthoPediatrics Corp.
Orthopedic · 159d
Cleared Jul 24, 2014
LINOS MOH HAND PLATING SYSTEM
K141489
KLS-Martin L.P.
Orthopedic · 49d
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 23, 2014
APTUS ULNA SHORTENING 2.5
K141232
Medartis AG
Orthopedic · 41d
Cleared Jun 13, 2014
ACUMED HAND FRACTURE SYSTEM
K141383
Acumed, LLC
Orthopedic · 17d
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 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 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 23, 2014
AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5
K133675
Aap Implantate AG
Orthopedic · 55d
Cleared Jan 07, 2014
D-RAD SMART PACK
K132296
Smith & Nephew, Inc.
Orthopedic · 168d
Cleared Jan 06, 2014
ACUMED HAND PLATING SYSTEM
K132769
Acumed, LLC
Orthopedic · 124d
Cleared Dec 24, 2013
LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE
K132787
Aap Implantate AG
Orthopedic · 109d
Cleared Dec 18, 2013
ARIX HAND LOCKING SYSTEM
K132876
Jeil Medical Corporation
Orthopedic · 96d
Cleared Dec 17, 2013
ZIMMER DISTAL RADIUS PLATING SYSTEM
K133246
Zimmer, Inc.
Orthopedic · 56d