ClearanceBrief
Panels › Orthopedic › Product code HSB · Class 2

Rod, Fixation, Intramedullary And Accessories

Regulation 888.3020

20510(k)s in 12 months (532 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
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Top companies in HSB

Company510(k)sRecalls
Zimmer Biomet, Inc.0295
DePuy Orthopaedics, Inc.9116
Zimmer GmbH2350
Stryker1237
Howmedica Osteonics390
OrthoPediatrics Corp.731
Ebi, L.P.131
Advanced Orthopaedic Solutions, Inc.1512
NuVasive Specialized Orthopedics189
Synthes (Usa)234
DateFirm and productCodeLinked 510(k)
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 70 mm; Product 903205070.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 65 mm; Product 903205065.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 60 mm; Product 903205060.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 120 mm; Product 903011120.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 115 mm; Product 903011115.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 110 mm; Product 903011110.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 105 mm; Product 903011105.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 100 mm; Product 903011100.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 95 mm; Product 903011095.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 90 mm; Product 903011090.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 85 mm; Product 903011085.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 80 mm; Product 903011080.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 75 mm; Product 903011075.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 70 mm; Product 903011070.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 65 mm; Product 903011065.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5mm x 60 mm; Product 903011060.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 120 mm; Product 903211120.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 115 mm; Product 903211115.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 110 mm; Product 903211110.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 105 mm; Product 903211105.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 100 mm; Product 903211100.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 95 mm; Product 903211095.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 90 mm; Product 903211090.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 85 mm; Product 903211085.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 80 mm; Product 903211080.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 75 mm; Product 903211075.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 70 mm; Product 903211070.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 65 mm; Product 903211065.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail lag screw; sterile, 60 mm; Product 903211060.
Terminated		 HSBK013563
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, standard, 140D 13 x 200 mm; Product 903013240.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, standard, 135D 13 x 200 mm; Product 903013235.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, standard, 130D 13 x 200 mm; Product 903013230.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, standard, 125D 13 x 200 mm; Product 903013225.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, standard, 140D 11 x 200 mm; Product 903011240.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, standard, 135D 11 x 200 mm; Product 903011235.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, standard, 130D 11 x 200 mm; Product 903011230.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, standard, 125D 11 x 200 mm; Product 903011225.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, short, 140D 9 x 180 mm; Product 903009140.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, short, 135D 9 x 180 mm; Product 903009135.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, short, 130D 9 x 180 mm; Product 903009130.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; non-sterile, short, 125D 9 x 180 mm; Product 903009125.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; sterile, standard, 140 deg x 13 mm; Product 903213240.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; sterile, standard, 135 deg x 13 mm; Product 903213235.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; sterile, standard, 130 deg x 13 mm; Product 903213230.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; sterile, standard, 125 deg x 13 mm; Product 903213225.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; sterile, short, 180 x 13 x 135; Product 903213135.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; sterile, short, 180 x 13 x 130; Product 903213130.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; sterile, short, 180 x 13 x 125; Product 903213125.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; sterile, stnadard, 140 deg x 11 mm; Product 903211240.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail; sterile, standard, 135 deg x 11 mm; Product 903211235.
Terminated		 HSBK010780

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