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
865–888 of 1333
Cleared Nov 20, 2009
AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
K092178
Howmedica Osteonics Corp.
Orthopedic · 122d
Cleared Nov 19, 2009
BIODRIVE MICRO SCREW SYSTEM
K092670
Ebi,Llc D/B/A Biomet Trauma
Orthopedic · 80d
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 05, 2009
PECTUS STRUT
K082399
Koros USA, Inc.
Orthopedic · 442d
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 Oct 27, 2009
IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION
K092381
Ibalance Medical, Inc.
Orthopedic · 83d
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 10, 2009
OSTEOMED FOOT PLATING SYSTEM
K091614
Osteomed LP
Orthopedic · 99d
Cleared Sep 01, 2009
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS
K092419
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Aug 28, 2009
WAVEON WRX BONE FIXATION SYSTEM
K090304
Sonoma Orthopedic Products, Inc.
Orthopedic · 203d
Cleared Aug 05, 2009
OPTILOCK PERIARTICULAR PLATING
K092078
Biomet Trauma
Orthopedic · 27d
Cleared Jul 30, 2009
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K092015
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Jul 24, 2009
LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,
K091294
DePuy Orthopaedics, Inc.
Orthopedic · 81d
Cleared Jul 22, 2009
ADKINS STRUT
K091058
Biomet Microfixation, Inc.
Orthopedic · 100d
Cleared Jul 15, 2009
TRIMED STERILE PRODUCT
K091156
TriMed, Inc.
Orthopedic · 85d
Cleared Jul 13, 2009
APTUS FOOT SYSTEM
K091479
Medartis AG
Orthopedic · 55d
Cleared Jul 10, 2009
NEWDEAL HALLU LOCK PLATE SYSTEM
K083154
Newdeal Sas
Orthopedic · 259d
Cleared Jul 02, 2009
OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM
K090522
Osteomed LP
Orthopedic · 126d
Cleared Jul 02, 2009
CALCANEAL FRACTURE PLATE SYSTEM
K090582
Tornier, Inc.
Orthopedic · 120d
Cleared Jul 01, 2009
APTUS 2.0/2.3 FOUR CORNER FUSION PLATE
K090983
Medartis AG
Orthopedic · 85d
Cleared Jun 30, 2009
NEWDEAL COMPRESSION PLATE
K091609
Newdeal Sas
Orthopedic · 27d