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
793–816 of 1333
Cleared Aug 02, 2011
ARTHREX DISTAL EXTREMITY PLATE SYSTEM
K111253
Arthrex, Inc.
Orthopedic · 90d
Cleared Jul 22, 2011
MAESTRO WRIST PLATING SYSTEM
K110271
Biomet Manufacturing Corp
Orthopedic · 172d
Cleared Jul 21, 2011
EXPLOR RADIAL HEAD PLATING SYSTEM
K110201
Biomet, Inc.
Orthopedic · 178d
Cleared Jul 21, 2011
COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM
K110320
Biomet Manufacturing Corp
Orthopedic · 168d
Cleared Jul 12, 2011
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES
K110670
Smith & Nephew, Inc.
Orthopedic · 125d
Cleared Jul 06, 2011
OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
K111326
Graham Medical Technologies, LLC
Orthopedic · 56d
Cleared Jun 28, 2011
APTUS FOOT 3.5 SYSTEM
K110908
Medartis AG
Orthopedic · 89d
Cleared Jun 17, 2011
ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
K111086
OrthoPediatrics Corp.
Orthopedic · 59d
Cleared Jun 06, 2011
MINI VARIABLE SYSTEM
K111041
Orthohelix Surgical Designs, Inc.
Orthopedic · 53d
Cleared May 19, 2011
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
K111039
Zimmer, Inc.
Orthopedic · 35d
Cleared May 18, 2011
BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
K110574
Biomet Microfixation, Inc.
Orthopedic · 78d
Cleared May 13, 2011
MAHE FIXATION PLATE AND SCREW SYSTEM
K102845
Mahe Medical GmbH
Orthopedic · 226d
Cleared Apr 21, 2011
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
K110125
Synthes (Usa)
Orthopedic · 93d
Cleared Apr 14, 2011
NEWDEAL COMPRESSION PLATES
K093914
Newdeal Sas
Orthopedic · 478d
Cleared Mar 18, 2011
AXSOS (TM) LOCKING PLATE SYSTEM
K110476
Stryker Corp.
Orthopedic · 28d
Cleared Mar 15, 2011
MEMOMETAL NAVIS BONE PLATING SYSTEM
K101930
Memometal Technologies
Orthopedic · 249d
Cleared Feb 24, 2011
PICCOLO COMPOSITE PLATE SYSTEM
K102597
N.M.B. Medical Applications, Ltd.
Orthopedic · 167d
Cleared Feb 15, 2011
AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS
K110176
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 25d
Cleared Jan 24, 2011
APTUS ULNA PLATES
K103332
Medartis AG
Orthopedic · 73d
Cleared Jan 21, 2011
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
K103243
Synthes (Usa)
Orthopedic · 81d
Cleared Jan 04, 2011
CONGRUENT BONE PLATE SYSTEM
K102998
Acumed, LLC
Orthopedic · 88d
Cleared Dec 16, 2010
POSTERIOR LATERAL PLATES
K103408
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Dec 15, 2010
CONTOURS LAPIDUS PLATING SYSTEM
K102201
Orthofix, Inc.
Orthopedic · 133d
Cleared Dec 10, 2010
APTUS 1.5 TRILOCK
K102537
Medartis AG
Orthopedic · 98d