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
505–528 of 1319
Cleared Nov 19, 2013
A.L.P.S. CALCANEAL PLATING SYSTEM
K132898
Biomet Manufacturing Corp
Orthopedic · 64d
Cleared Nov 18, 2013
LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5
K131782
Aap Implantate AG
Orthopedic · 154d
Cleared Nov 04, 2013
ARIX HAND SYSTEM
K131566
Jeil Medical Corporation
Orthopedic · 158d
Cleared Oct 29, 2013
2.5MM INLINE FUSION PLATE
K131867
Biomet, Inc.
Orthopedic · 127d
Cleared Oct 08, 2013
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
K131186
Synthes USA Products, LLC
Orthopedic · 166d
Cleared Oct 03, 2013
AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5
K132554
Aap Implantate AG
Orthopedic · 50d
Cleared Sep 25, 2013
ARTHREX COMPRESSION PLATES
K130510
Arthrex, Inc.
Orthopedic · 210d
Cleared Sep 05, 2013
ARIX FOOT SYSTEM
K131311
Jeil Medical Corporation
Orthopedic · 121d
Cleared Sep 05, 2013
ACUMED WRIST SPANNING PLATE
K131764
Acumed, LLC
Orthopedic · 80d
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
Cleared Jun 10, 2013
ACUMED TOTALW RIST FUSION PLATING SYSTEM
K131380
Acumed, LLC
Orthopedic · 27d
Cleared May 21, 2013
ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
K131093
Wrightmedicaltechnologyinc
Orthopedic · 33d
Cleared Apr 05, 2013
ARTHREX FRACTURE PLATES
K123241
Arthrex, Inc.
Orthopedic · 170d
Cleared Mar 28, 2013
BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
K122770
Biomet Manufacturing Corp
Orthopedic · 199d
Cleared Mar 11, 2013
AAP RADIUS SET 2.5
K123875
Aap Implantate AG
Orthopedic · 84d
Cleared Feb 14, 2013
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
K123918
Zimmer, Inc.
Orthopedic · 57d
Cleared Jan 25, 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055
Smith & Nephew, Inc.
Orthopedic · 116d
Cleared Dec 21, 2012
INTEGRA TOTAL FOOT SYSTEMS
K123000
Integra LifeSciences Corporation
Orthopedic · 85d
Cleared Dec 07, 2012
LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
K121495
Aap Implantate AG
Orthopedic · 200d
Cleared Nov 19, 2012
LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING
K121494
Aap Implantate AG
Orthopedic · 182d
Cleared Nov 19, 2012
ACUMED PELVIC BONE PLATE SYSTEM
K122538
Acumed, LLC
Orthopedic · 90d
Cleared Nov 14, 2012
KLS MARTIN RECON TALON
K122860
KLS-Martin L.P.
Orthopedic · 57d
Cleared Nov 08, 2012
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
K113601
Aap Implantate AG
Orthopedic · 339d