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
1201–1224 of 1322
Cleared Feb 15, 1994
BONE PLATE
K931244
Acu Med, Inc.
Orthopedic · 341d
Cleared Jul 26, 1993
ACE UNIVERSAL RECONSTRUCTION PLATE
K930592
Ace Medical Co.
Orthopedic · 172d
Cleared Apr 14, 1993
ALPHATEC 130 COMPRESSION HIP SCREW
K925500
Alphatec Mfg., Inc.
Orthopedic · 166d
Cleared Mar 04, 1993
LUHR PAN FIXATION SYSTEM
K923861
Howmedica Corp.
Orthopedic · 216d
Cleared Feb 10, 1993
ANSPACH MINI-PLATING SYSTEM
K921338
The Anspach Effort, Inc.
Orthopedic · 329d
Cleared Dec 17, 1992
RECONSTRUCTION PLATE SYSTEM
K924085
Sofamor Danek Mfg., Inc.
Orthopedic · 126d
Cleared Sep 22, 1992
DALL MILES BROAD BONE PLATE
K922525
Howmedica Corp.
Orthopedic · 117d
Cleared Aug 06, 1992
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K922167
Alphatec Mfg., Inc.
Orthopedic · 90d
Cleared Jul 17, 1992
TMP MICROPLATING SYSTEM
K921458
Techmedica, Inc.
Orthopedic · 112d
Cleared Jul 02, 1992
ALPHATEC COMPRESSION HIP SCREW SYSTEM
K921622
Alphatec Mfg., Inc.
Orthopedic · 87d
Cleared Apr 29, 1992
RADIUS OSTEOTOMY PLATES
K914804
Link America, Inc.
Orthopedic · 188d
Cleared Apr 28, 1992
SCHWABE RADIUS PLATES
K914803
Link America, Inc.
Orthopedic · 187d
Cleared Jan 17, 1992
SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
K915818
Synthes (Usa)
Orthopedic · 18d
Cleared Dec 02, 1991
LUHR PAN FIXATION SYSTEM
K913355
Howmedica Corp.
Orthopedic · 126d
Cleared Sep 25, 1991
SYNTHES MAXILLOFACIAL TITANIUM MICRO SET
K912932
Synthes (Usa)
Orthopedic · 82d
Cleared Sep 06, 1991
MAY HUMERUS PLATES
K912936
Turnkey Intergration USA, Inc.
Orthopedic · 63d
Cleared Sep 05, 1991
MASTERPIECES(TM)/MICRO/MINI SYSTEMS
K913289
Storz Instrument Co.
Orthopedic · 43d
Cleared Jul 30, 1991
ALTA CHANNEL PLATE CONNECTOR
K910482
Howmedica Corp.
Orthopedic · 174d
Cleared Jul 26, 1991
MASTERPIECES MICRO SYSTEM
K910957
Storz Instrument Co.
Orthopedic · 142d
Cleared Jun 24, 1991
TMP MANDIBULAR COMPRESSION SYSTEM
K905024
Techmedica, Inc.
Orthopedic · 229d
Cleared Jun 13, 1991
THACKRAY TITANIUM MINI-PLATING SYSTEM
K905774
Depuy, Inc.
Orthopedic · 168d
Cleared Mar 14, 1991
ACE RECONSTRUCTIVE PLATE
K905595
Ace Medical Co.
Orthopedic · 91d
Cleared Jan 04, 1991
BROAD SELF-COMPRESSING PLATE
K905355
O'Tec Corp.
Orthopedic · 37d
Cleared Aug 09, 1990
BROAD SELF-COMPRESSING PLATE
K903252
Onyx Medical Corp.
Orthopedic · 16d