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
1177–1200 of 1322
Cleared Jun 12, 1995
LUHR TITANIUM PAN FIXATION SYSTEM
K945139
Howmedica Corp.
Orthopedic · 235d
Cleared May 16, 1995
ORTHOMET ACETABULAR ROOF REINFORCEMENT RING
K944856
Wrightmedicaltechnologyinc
Orthopedic · 225d
Cleared May 10, 1995
ACE SUPRACONDYLAR PLATE
K950618
Ace Medical Co.
Orthopedic · 89d
Cleared Apr 13, 1995
BONE PLATE SYSTEM
K942359
Acu Med, Inc.
Orthopedic · 331d
Cleared Apr 10, 1995
LUHR(R) TITANIUM ALLOY BURR HOLE COVERS
K950105
Howmedica Corp.
Orthopedic · 89d
Cleared Apr 10, 1995
LUHR(R) TITANIUM BURR HOLE COVERS
K950115
Howmedica, Inc.
Orthopedic · 89d
Cleared Jan 20, 1995
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K943853
Wrightmedicaltechnologyinc
Orthopedic · 165d
Cleared Aug 01, 1994
PELVIC RADIUS PLATE
K936233
Smith & Nephew Richards, Inc.
Orthopedic · 215d
Cleared Jun 15, 1994
VARIABLE ANGULAR HOLD BONE PLATE SYSTEM
K930480
Smith & Nephew Richards, Inc.
Orthopedic · 502d
Cleared Jun 07, 1994
SPOON PLATE
K931690
Onyx Medical Corp.
Orthopedic · 428d
Cleared May 04, 1994
EPIPHYSIS PLATE
K931684
Onyx Medical Corp.
Orthopedic · 394d
Cleared May 04, 1994
T-PLATE
K931692
Onyx Medical Corp.
Orthopedic · 394d
Cleared May 04, 1994
MINI FRAGMENT PLATE
K934614
Onyx Medical Corp.
Orthopedic · 219d
Cleared Apr 25, 1994
BUTTRESS PLATE
K931679
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
CLOVERLEAF PLATE
K931683
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
FOREARM SELF COMPRESSION PLATE
K931685
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
MULTIPLE FRAGMENT PLATE
K931687
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
SEMI-TUBULAR PLATE
K931688
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
SMALL STRAIGHT PLATE
K931689
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
STRAIGHT MINI-PLATE
K931691
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
1/3 TUBULAR PLATE
K931693
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
1/4 TUBULAR PLATE
K931694
Onyx Medical Corp.
Orthopedic · 385d
Cleared Feb 23, 1994
LUHR MINI BONE SCREW AND Z PLATE
K935448
Howmedica Corp.
Orthopedic · 103d
Cleared Feb 17, 1994
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K933112
Alphatec Mfg., Inc.
Orthopedic · 237d