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
841–864 of 1322
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 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 15, 2009
TRIMED STERILE PRODUCT
K091156
TriMed, Inc.
Orthopedic · 85d
Cleared Jul 13, 2009
APTUS FOOT SYSTEM
K091479
Medartis AG
Orthopedic · 55d
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 26, 2009
PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS
K090877
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Jun 26, 2009
ORTHOLOC ANKLE PLATING SYSTEM (APS)
K091243
Wrightmedicaltechnologyinc
Orthopedic · 59d
Cleared Jun 15, 2009
CLAVICLE PLATING SYSTEM
K090289
Orthohelix Surgical Designs, Inc.
Orthopedic · 130d
Cleared Jun 04, 2009
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
K090675
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared May 08, 2009
ORTHOLOC 2.0/2.4 PLATE SYSTEM
K090692
Wrightmedicaltechnologyinc
Orthopedic · 53d
Cleared Apr 24, 2009
PEDIPLATES
K090666
OrthoPediatrics Corp.
Orthopedic · 42d
Cleared Apr 23, 2009
APTUS 2.0 RADIAL HEAD SYSTEM
K090053
Medartis AG
Orthopedic · 105d
Cleared Apr 01, 2009
SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM
K090047
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 31, 2009
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
K090492
DePuy Orthopaedics, Inc.
Orthopedic · 34d
Cleared Mar 20, 2009
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
K083843
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Mar 06, 2009
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
K083694
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 04, 2009
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
K083573
Synthes (Usa)
Orthopedic · 91d
Cleared Feb 26, 2009
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)
K083654
Zimmer, Inc.
Orthopedic · 78d
Cleared Feb 18, 2009
ANATOMIC LOCKING PLATING SYSTEM
K082300
DePuy Orthopaedics, Inc.
Orthopedic · 190d