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..

1333
Total
1333
Cleared
115d
Avg days
1976
Since
1333 devices
841–864 of 1333
Cleared May 13, 2010
VARIAX ELBOW SYSTEM
K101056
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared May 11, 2010
SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES
K092812
Synthes (Usa)
Orthopedic · 239d
Cleared May 11, 2010
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
K093978
Exactech, Inc.
Orthopedic · 138d
Cleared Apr 30, 2010
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
K100475
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Apr 20, 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
K100618
Orthohelix Surgical Designs, Inc.
Orthopedic · 47d
Cleared Apr 16, 2010
PEANUT GROWTH CONTROL PLATING SYSTEM
K093880
Ebi, L.P.
Orthopedic · 119d
Cleared Apr 12, 2010
DEROYAL NON-LOCKING BONE FIXATION SYSTEM
K090975
Deroyal Industries, Inc.
Orthopedic · 371d
Cleared Apr 12, 2010
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K100111
Zimmer, Inc.
Orthopedic · 88d
Cleared Apr 08, 2010
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
K100676
Synthes (Usa)
Orthopedic · 29d
Cleared Mar 29, 2010
GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM
K092493
Gpc Medical, Ltd.
Orthopedic · 227d
Cleared Mar 29, 2010
SYNTHES STERNAL FIXATION SYSTEM
K093772
Synthes
Orthopedic · 111d
Cleared Mar 29, 2010
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
K093928
Synthes (Usa)
Orthopedic · 97d
Cleared Mar 19, 2010
SMPLE PLATE AND SCREWS
K093983
Biomet Trauma (Aka Ebi, Lp)
Orthopedic · 85d
Cleared Mar 10, 2010
TC PLATING SYSTEM
K094037
Ortho-Pro, LLC
Orthopedic · 70d
Cleared Mar 05, 2010
OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM
K093761
Biomet Trauma (Aka Ebi, Lp)
Orthopedic · 88d
Cleared Feb 17, 2010
EDGELOCK
K093900
Orthohelix Surgical Designs, Inc.
Orthopedic · 61d
Cleared Feb 05, 2010
ORTHO SELECT BONE PLATES AND SCREW SYSTEM
K091493
Ortho Select Implant Technology Gesellschaft
Orthopedic · 261d
Cleared Feb 02, 2010
DEPUY FRACTURE AND FUSION PLATING SYSTEM
K093474
DePuy Orthopaedics, Inc.
Orthopedic · 88d
Cleared Feb 02, 2010
EVOLVE EPS ORTHOLOC
K100146
Wrightmedicaltechnologyinc
Orthopedic · 14d
Cleared Jan 28, 2010
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
K093433
Howmedica Osteonics Corp.
Orthopedic · 85d
Cleared Jan 22, 2010
MODIFIED: NEWDEAL HALLU PLATES
K093781
Newdeal Sas
Orthopedic · 44d
Cleared Jan 22, 2010
BIOFOAM BONE WEDGE MODEL ASSORTED
K093950
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Dec 23, 2009
SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES
K091644
Synthes (Usa)
Orthopedic · 202d
Cleared Dec 15, 2009
INTEGRA TOTAL WRIST FUSION SYSTEM
K093163
Integra LifeSciences Corporation
Orthopedic · 70d