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
553–576 of 1311
Cleared Apr 12, 2006
STRYKER PLATING SYSTEM
K060798
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Mar 17, 2006
STRYKER PLATING SYSTEM
K060514
Howmedica Osteonics Corp.
Orthopedic · 18d
Cleared Dec 12, 2005
ARTHREX TENSIONLOK
K052901
Arthrex, Inc.
Orthopedic · 59d
Cleared Dec 05, 2005
SYNTHES (USA) STERNAL FIXATION SYSTEM
K052683
Synthes (Usa)
Orthopedic · 68d
Cleared Oct 12, 2005
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)
K052677
Synthes (Usa)
Orthopedic · 14d
Cleared Oct 07, 2005
SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
K052390
Synthes (Usa)
Orthopedic · 37d
Cleared Sep 28, 2005
LOW PROFILE PLATE AND SCREW SYSTEM
K052614
Arthrex, Inc.
Orthopedic · 5d
Cleared Sep 08, 2005
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
K051986
Synthes (Usa)
Orthopedic · 48d
Cleared Aug 10, 2005
CHARLOTTE COMPRESSION PLATE
K051908
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Aug 05, 2005
CHARLOTTE SMALL MTP FUSION PLATE
K051884
Wrightmedicaltechnologyinc
Orthopedic · 24d
Cleared Jul 19, 2005
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY
K051735
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Apr 26, 2005
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K050646
Synthes (Usa)
Orthopedic · 43d
Cleared Apr 11, 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
K050607
Synthes (Usa)
Orthopedic · 32d
Cleared Mar 21, 2005
STRYKER LOCKED PLATING SYSTEM
K050512
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Mar 04, 2005
SYNTHES (USA) LCP MODULAR FOOT PLATES
K050110
Synthes (Usa)
Orthopedic · 45d
Cleared Jan 31, 2005
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359
K050121
Zimmer, Inc.
Orthopedic · 12d
Cleared Jan 21, 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359
K043560
Zimmer, Inc.
Orthopedic · 25d
Cleared Dec 10, 2004
PERIARTICULAR LOCKING PLATES, 2358 SERIES
K043227
Zimmer, Inc.
Orthopedic · 18d
Cleared Oct 29, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES
K042598
Zimmer, Inc.
Orthopedic · 36d
Cleared Oct 27, 2004
SYNTHES (USA) LCP WRIST FUSION PLATES
K042355
Synthes (Usa)
Orthopedic · 57d
Cleared Oct 07, 2004
SYNTHES LOW PROFILE RECONSTRUCTION PLATES
K042377
Synthes (Usa)
Orthopedic · 36d
Cleared Sep 20, 2004
BONE FUSION PLATE SYSTEM
K042205
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Sep 08, 2004
SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG
K041860
Synthes (Usa)
Orthopedic · 61d
Cleared Sep 08, 2004
ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
K041965
Arthrex, Inc.
Orthopedic · 49d