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
1225–1248 of 1322
Cleared Apr 04, 1990
BONE PLATE
K893201
Karlin Technology, Inc.
Orthopedic · 343d
Cleared Oct 06, 1989
INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM
K892228
Intermedics Orthopedics
Orthopedic · 184d
Cleared May 22, 1989
DUPONT DISTAL HUMERAL NAIL
K890939
Howmedica Corp.
Orthopedic · 87d
Cleared Feb 27, 1989
ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES
K890641
Acufex Microsurgical, Inc.
Orthopedic · 19d
Cleared Feb 13, 1989
ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS
K885250
Howmedica Corp.
Orthopedic · 53d
Cleared Aug 19, 1988
LUHR MICRO SYSTEM
K882454
Howmedica Corp.
Orthopedic · 66d
Cleared Jan 14, 1988
ORTHOMET BONE PLATES
K875086
Orthomet, Inc.
Orthopedic · 36d
Cleared Sep 01, 1987
TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS
K873005
Techmedica, Inc.
Orthopedic · 28d
Cleared Apr 03, 1987
HOFFMANN LEG LENGTHENING PLATE SYSTEM
K870388
Howmedica Corp.
Orthopedic · 63d
Cleared Mar 20, 1987
KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM
K864924
Kirschner Medical Corp.
Orthopedic · 94d
Cleared Jul 08, 1986
WARSAW ORTHOPEDIC BONE PLATE
K862254
Warsaw Orthopedic, Inc.
Orthopedic · 25d
Cleared Mar 13, 1986
SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION
K860600
3M Company
Orthopedic · 22d
Cleared Mar 10, 1986
ACE MULTIPLE PIN PLATE
K860591
Buckman Co., Inc.
Orthopedic · 19d
Cleared Jan 21, 1986
LINK SMALL BONE PLATES
K854825
Link America, Inc.
Orthopedic · 49d
Cleared Nov 15, 1985
A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM
K853709
Downs Surgical , Ltd.
Orthopedic · 72d
Cleared Apr 19, 1985
LETOURNEL ACETABULAR PLATE
K850401
Pfizer, Inc.
Orthopedic · 77d
Cleared Apr 19, 1985
MEC BROAD BONE PLATE
K850442
Pfizer, Inc.
Orthopedic · 73d
Cleared Apr 19, 1985
MEC BUTRESS PLATE
K850444
Pfizer, Inc.
Orthopedic · 73d
Cleared May 11, 1984
DYNAMIC CONDYLAR SCREW OR D.C.S.
K840954
Synthes (Usa)
Orthopedic · 67d
Cleared Dec 12, 1983
ACE BROOKER BONE PLATING SYSTEM
K833865
Buckman Co., Inc.
Orthopedic · 35d
Cleared Jun 23, 1981
CRYOPHTHALMIC UNIT
K811244
Keeler Instruments, Inc.
Orthopedic · 50d
Cleared Jan 23, 1981
CURVED SHERMAN BONE PLATE
K810061
Howmedica Corp.
Orthopedic · 10d
Cleared Oct 03, 1980
POLYETHYLENE FILLED BONE PLATE
K801603
Zimmer, Inc.
Orthopedic · 81d
Cleared Apr 21, 1980
I.C.S. MINI & SMALL FRAGMENT SET
K800806
Howmedica Corp.
Orthopedic · 11d