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)
Sep 22, 2009EBI, L.P.
TI Cann Partl Thd Recon Screw 6.00MM x 95MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in
Terminated		 HSBK072161
Sep 22, 2009EBI, L.P.
TI Cann Partl Thd Recon Screw 6.00MM x 90MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in
Terminated		 HSBK072161
Sep 22, 2009EBI, L.P.
TI Cann Partl Thd Recon Screw 6.00MM x 85MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in
Terminated		 HSBK072161
Sep 22, 2009EBI, L.P.
TI Cann Partl Thd Recon Screw 6.00MM x 80MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in
Terminated		 HSBK072161
Sep 22, 2009EBI, L.P.
TI Cann Partl Thd Recon Screw 6.00MM x 75MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in
Terminated		 HSBK072161
Sep 22, 2009EBI, L.P.
TI Cann Partl Thd Recon Screw 6.00MM x 70MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in
Terminated		 HSBK072161
Sep 22, 2009EBI, L.P.
TI Cann Partl Thd Recon Screw 6.00MM x 65MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation device intended to aid in
Terminated		 HSBK072161
Sep 21, 2009EBI, L.P.
Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx only Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 Intended to aid in the alignment and stabilization of f
Terminated		 HSBK982953
Sep 21, 2009EBI, L.P.
Phoenix Cannulated Recon Screw; Ti-Cann PARTL THD Recon Screw Trauma Fixation Systems; Rx only Biomet Trauma, 100 Interpace Parkway, Parsippany, NJ 077054 Intended to aid in the alignment and stabili
Terminated		 HSBK072161
Aug 18, 2009Stryker Howmedica Osteonics Corp.
T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker Orthopaedics The Surgical Protocol instructs surgeons on proper surgical technique for the T2 Ankle Arthrodesis Nail.
Terminated		 HSBK051590
Aug 4, 2009Zimmer Inc.
Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United States).
Terminated		 HSBK032367
Aug 4, 2009Zimmer Inc.
Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00.
Terminated		 HSBK032367
May 18, 2009Zimmer Inc.
Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. The device is used in orthopedic trauma surgeries for s
Terminated		 HSBK043270
Sep 16, 2008Integra LifeSciences Corp.
PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plainsboro, NJ. The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and the treatment of
Terminated		 HSBK050882
Sep 16, 2008Smith & Nephew Inc
TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot
Terminated		 HSBK043052
Sep 16, 2008Smith & Nephew Inc
TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Right, REF 71701120R. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot
Terminated		 HSBK043052
Sep 16, 2008Smith & Nephew Inc
TRIGEN Hind Foot Fusion Nail, 10mm X 16mm Left, REF 71701016L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
Terminated		 HSBK043052
Sep 16, 2008Smith & Nephew Inc
TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
Terminated		 HSBK043052
Sep 16, 2008Smith & Nephew Inc
TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Left, REF 71701120L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
Terminated		 HSBK043052
Sep 16, 2008Smith & Nephew Inc
TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF 71701125L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
Terminated		 HSBK043052
Sep 16, 2008Smith & Nephew Inc
TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
Terminated		 HSBK043052
Oct 15, 2005Stryker Howmedica Osteonics Corp.
T2 Recon Nail System.
Terminated		 HSBK032898
Jul 20, 2004Zimmer Inc.
M/DN Intramedullary Fixation Humeral Nail
Terminated		 HSBK965098
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, non-sterile, 25 mm; Product 903008025.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, non-sterile, 20 mm; Product 903008020.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, non-sterile, 15 mm; Product 903008015.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, non-sterile, 10 mm; Product 903008010.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, non-sterile, 5 mm; Product 903208005.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, non-sterile, 0 mm; Product 903008000.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, sterile, 25 mm; Product 903208025.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, sterile, 20 mm; Product 903208020.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, sterile, 15 mm; Product 903208015.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, sterile, 10 mm; Product 903208010.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, sterile, 5 mm; Product 903208005.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail end cap, sterile; Product 903208000.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 100 mm; Product 903005100.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 95 mm; Product 903005095.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 90 mm; Product 903005090.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 85 mm; Product 903005085.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 80 mm; Product 903005080.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 75 mm; Product 903005075.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 70 mm; Product 903005070.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 65 mm; Product 903005065.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 60 mm; Product 903005060.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 100 mm; Product 903205100.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 95 mm; Product 903205095.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 90 mm; Product 903205090.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 85 mm; Product 903205085.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 80 mm; Product 903205080.
Terminated		 HSBK010780
Jan 31, 2004Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation superior screw; sterile, 75 mm; Product 903205075.
Terminated		 HSBK010780

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