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
Cleared
Jun 23, 1981
CRYOPHTHALMIC UNIT
Keeler Instruments, Inc.
Orthopedic
50d
Cleared
Jan 23, 1981
CURVED SHERMAN BONE PLATE
Howmedica Corp.
Orthopedic
10d
Cleared
Oct 03, 1980
POLYETHYLENE FILLED BONE PLATE
Zimmer, Inc.
Orthopedic
81d
Cleared
Apr 21, 1980
I.C.S. MINI & SMALL FRAGMENT SET
Howmedica Corp.
Orthopedic
11d
Cleared
Jan 10, 1979
MULTIPLICITY OF PRODUCTS
Depuy, Inc.
Orthopedic
14d
Cleared
Jan 26, 1977
B.G. COMPRESSION SYSTEM
Howmedica Corp.
Orthopedic
5d
Cleared
Dec 16, 1976
GALLENAUGH BONE PLATES
Orthopedic Equipment Co., Inc.
Orthopedic
20d