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
769–792 of 1322
Cleared Oct 26, 2011
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K112174
Zimmer, Inc.
Orthopedic · 90d
Cleared Oct 26, 2011
SYNTHES STERNAL FIXATION SYSTEM
K112689
Synthes, Inc.
Orthopedic · 41d
Cleared Oct 24, 2011
LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT
K103513
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 328d
Cleared Oct 07, 2011
OSTEOMED HAND FUSION SYSTEM
K111419
Osteomed LP
Orthopedic · 140d
Cleared Oct 06, 2011
EASYLOCK OSTEOSYSTEM
K111266
TriMed, Inc.
Orthopedic · 155d
Cleared Sep 22, 2011
AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
K112455
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 28d
Cleared Sep 09, 2011
IFS PROFILE PLATES, SCREWS, AND WASHERS
K110086
Internal Fixation Systems, Inc.
Orthopedic · 240d
Cleared Aug 23, 2011
SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS
K111620
Skeletal Dynamics, LLC
Orthopedic · 74d
Cleared Aug 19, 2011
TRIMED RADIOCARPAL FUSION SYSTEM
K102785
TriMed, Inc.
Orthopedic · 326d
Cleared Aug 19, 2011
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
K111432
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Aug 08, 2011
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K111540
Synthes (Usa)
Orthopedic · 67d
Cleared Aug 05, 2011
ORTHOPEDIATRICS BLADE PLATE SYSTEM
K110959
OrthoPediatrics Corp.
Orthopedic · 122d
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 Apr 21, 2011
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
K110125
Synthes (Usa)
Orthopedic · 93d