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
913–936 of 1322
Cleared Jul 27, 2007
DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07)
K063275
Terray Corp.
Orthopedic · 270d
Cleared Jul 26, 2007
BIOMET VARIABLE LOCKING PLATE SYSTEM
K071325
Biomet Trauma
Orthopedic · 77d
Cleared Jul 18, 2007
ACUMED CONGRUENT BONE PLATE SYSTEM
K071715
Acumed, LLC
Orthopedic · 26d
Cleared Jul 09, 2007
SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE
K071264
Synthes (Usa)
Orthopedic · 66d
Cleared Jun 22, 2007
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
K071184
Synthes (Usa)
Orthopedic · 53d
Cleared Jun 06, 2007
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES
K070946
Synthes (Usa)
Orthopedic · 63d
Cleared May 30, 2007
SBI DISTAL RADIUS VOLAR PLATING SYSTEM
K070793
Small Bone Innovations, Inc.
Orthopedic · 69d
Cleared May 07, 2007
GROWTH CONTROL PLATING SYSTEM
K070823
Biomet Trauma
Orthopedic · 42d
Cleared Mar 29, 2007
NEWDEAL COMPRESSION PLATE
K070447
Newdeal Sas
Orthopedic · 42d
Cleared Mar 28, 2007
SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES
K070208
Synthes (Usa)
Orthopedic · 65d
Cleared Mar 26, 2007
KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE
K070169
KLS-Martin L.P.
Orthopedic · 67d
Cleared Mar 15, 2007
STRYKER FOOT PLATING SYSTEM
K063875
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared Mar 06, 2007
PLC SUTURE ANCHOR
K063726
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 81d
Cleared Mar 02, 2007
DALL-MILES SYSTEM
K070170
Stryker Orthopaedics
Orthopedic · 43d
Cleared Feb 08, 2007
LISFRANC PLATE
K063820
New Deal, S.A.
Orthopedic · 44d
Cleared Feb 08, 2007
MODIFICATION TO TTC PLATES
K070160
New Deal, S.A.
Orthopedic · 22d
Cleared Feb 08, 2007
MODIFICATION TO LAPIDUS PLATE
K070241
New Deal, S.A.
Orthopedic · 14d
Cleared Feb 07, 2007
BASAL DORSAL PLATES
K063831
Newdeal Sas
Orthopedic · 43d
Cleared Feb 02, 2007
FIBULA PLATE PROLOCK WITH ANGULAR STABILITY
K063672
I.T.S. Implantat-Technologie-Systeme GmbH
Orthopedic · 53d
Cleared Jan 23, 2007
INION CPS/OTPS FREEDOMPLATE
K063410
Inion , Ltd.
Orthopedic · 71d
Cleared Jan 04, 2007
TS-BONE HIP TOOL
K063709
Orthopedic Sciences, Inc.
Orthopedic · 21d
Cleared Dec 27, 2006
FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)
K063009
Praesidia S.R.L.
Orthopedic · 86d
Cleared Dec 22, 2006
HUMERUS LOCKING PLATING SYSTEM
K063095
Newclip Technics
Orthopedic · 73d
Cleared Dec 22, 2006
I.T.S. PELVIC RECONSTRUCTION SYSTEM
K063166
I.T.S. Implantat-Technologie-Systeme GmbH
Orthopedic · 65d