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
1153–1176 of 1333
Cleared May 23, 2001
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
K011237
Biomet, Inc.
Orthopedic · 30d
Cleared Dec 05, 2000
DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
K002775
Hand Innovations, Inc.
Orthopedic · 90d
Cleared Nov 24, 2000
COD COMPRESSION OSTEOTOMY DEVICE
K002184
Walter Abendschein, M.D.
Orthopedic · 128d
Cleared Nov 09, 2000
PRECIMED TRAUMA SYSTEM
K002486
Patrick Berdoz
Orthopedic · 87d
Cleared Nov 06, 2000
PE.R.I. II KNEE FRACTURE SYSTEM
K003235
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Oct 31, 2000
SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM
K002361
Synthes (Usa)
Orthopedic · 89d
Cleared Sep 29, 2000
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)
K002710
Synthes (Usa)
Orthopedic · 29d
Cleared Sep 22, 2000
SYNTHES MODULAR FOOT SYSTEM
K001941
Synthes (Usa)
Orthopedic · 88d
Cleared Sep 22, 2000
SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES
K001945
Synthes (Usa)
Orthopedic · 88d
Cleared Aug 07, 2000
LACTOSORB PANELS AND FASTENERS
K984390
Biomet, Inc.
Orthopedic · 608d
Cleared Jul 24, 2000
MACROSORBOS PROTECTIVE SHEET
K994158
Macropore Biosurgery, Inc.
Orthopedic · 228d
Cleared Jun 20, 2000
SYNTHES (USA) ORIBITAL MESH PLATES
K001311
Synthes (Usa)
Orthopedic · 56d
Cleared May 11, 2000
STRYKER TRAUMA PLATING SYSTEM
K000636
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared Mar 15, 2000
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
K000066
Synthes (Usa)
Orthopedic · 65d
Cleared Feb 14, 2000
LOCON-T DISTAL RADIAL PLATE
K994061
Wrightmedicaltechnologyinc
Orthopedic · 75d
Cleared Jan 11, 2000
DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE
K993465
Depuy, Inc.
Orthopedic · 90d
Cleared Dec 20, 1999
LACTOSORB TRAUMA PLATING SYSTEM
K992355
Biomet, Inc.
Orthopedic · 159d
Cleared Dec 09, 1999
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
K993106
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Nov 16, 1999
MODIFIED BMP TROCHANTERIC PLATES
K993510
Biomet, Inc.
Orthopedic · 29d
Cleared Nov 08, 1999
LORENZ SMALL FRAGMENT SYSTEM
K992961
Walter Lorenz Surgical, Inc.
Orthopedic · 67d
Cleared Aug 17, 1999
KMI WRIST FUSION SYSTEM
K991873
Kinetikos Medical, Inc.
Orthopedic · 76d
Cleared Jul 30, 1999
LACTOSORB HAND SYSTEM
K991763
Biomet, Inc.
Orthopedic · 67d
Cleared Apr 29, 1999
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K990596
Avanta Orthopaedics, Inc.
Orthopedic · 64d
Cleared Mar 23, 1999
DEPUY ACE SPIDER PLATE
K990392
Depuy Ace Medical Co.
Orthopedic · 42d