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..

1311
Total
1311
Cleared
116d
Avg days
1976
Since
1311 devices
481–504 of 1311
Cleared Jan 21, 2011
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
K103243
Synthes (Usa)
Orthopedic · 81d
Cleared Dec 09, 2010
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
K102694
Synthes (Usa)
Orthopedic · 80d
Cleared Dec 02, 2010
EVOLVE EPS ORTHOLOC
K102352
Wrightmedicaltechnologyinc
Orthopedic · 105d
Cleared Nov 23, 2010
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
K102429
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Aug 03, 2010
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K100776
Synthes (Usa)
Orthopedic · 138d
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 Apr 30, 2010
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
K100475
Howmedica Osteonics Corp.
Orthopedic · 71d
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 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 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 Sep 25, 2009
SYNTHES LOCKING HAND PLATES
K092247
Synthes (Usa)
Orthopedic · 59d
Cleared Sep 23, 2009
VARIAX ELBOW SYSTEM LINE EXTENSION
K092671
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Sep 01, 2009
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS
K092419
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Jul 30, 2009
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K092015
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Jun 26, 2009
ORTHOLOC ANKLE PLATING SYSTEM (APS)
K091243
Wrightmedicaltechnologyinc
Orthopedic · 59d