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
817–840 of 1322
Cleared May 14, 2010
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
K100271
Howmedica Osteonics Corp.
Orthopedic · 105d
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
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
K093928
Synthes (Usa)
Orthopedic · 97d
Cleared Feb 17, 2010
EDGELOCK
K093900
Orthohelix Surgical Designs, Inc.
Orthopedic · 61d
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
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
Cleared Nov 20, 2009
AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
K092178
Howmedica Osteonics Corp.
Orthopedic · 122d
Cleared Nov 17, 2009
SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS
K092556
Synthes (Usa)
Orthopedic · 89d
Cleared Nov 17, 2009
SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)
K092609
Synthes (Usa)
Orthopedic · 84d
Cleared Nov 02, 2009
DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM
K092317
Deroyal Industries, Inc.
Orthopedic · 90d
Cleared Oct 27, 2009
ANKLE ARTHRODESIS PLATE SYSTEM
K090139
Tornier, Inc.
Orthopedic · 279d
Cleared Sep 25, 2009
SYNTHES LOCKING HAND PLATES
K092247
Synthes (Usa)
Orthopedic · 59d