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
Cleared
Dec 02, 1991
LUHR PAN FIXATION SYSTEM
Howmedica Corp.
Orthopedic
126d
Cleared
Sep 25, 1991
SYNTHES MAXILLOFACIAL TITANIUM MICRO SET
Synthes (Usa)
Orthopedic
82d
Cleared
Jul 30, 1991
ALTA CHANNEL PLATE CONNECTOR
Howmedica Corp.
Orthopedic
174d
Cleared
Jun 13, 1991
THACKRAY TITANIUM MINI-PLATING SYSTEM
Depuy, Inc.
Orthopedic
168d
Cleared
May 22, 1989
DUPONT DISTAL HUMERAL NAIL
Howmedica Corp.
Orthopedic
87d
Cleared
Feb 13, 1989
ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS
Howmedica Corp.
Orthopedic
53d
Cleared
Aug 19, 1988
LUHR MICRO SYSTEM
Howmedica Corp.
Orthopedic
66d
Cleared
Apr 03, 1987
HOFFMANN LEG LENGTHENING PLATE SYSTEM
Howmedica Corp.
Orthopedic
63d
Cleared
Mar 13, 1986
SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION
3M Company
Orthopedic
22d
Cleared
May 11, 1984
DYNAMIC CONDYLAR SCREW OR D.C.S.
Synthes (Usa)
Orthopedic
67d
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