ClearanceBrief
Panels › Orthopedic › Product code HTW · Class 1

Bit, Drill

Regulation 888.4540

0510(k)s in 12 months (11 all time)
2recalls in 12 months (114 all time)
12recalls that name a 510(k)
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Top companies in HTW

DateFirm and productCodeLinked 510(k)
Jan 11, 2012Interventional Spine Inc
Single Use PERPOS PLS System, Catalog #9045-01 Catalog#9045-01 for Single Use PERPOS PLS System- a sterile, medical device kit consisting of the components: PERPOS Access Needle, PERPOS K-Wires, PERP
Terminated
HTWNone listed
Jan 11, 2012Interventional Spine Inc
PERPOS 2-in-1 Drills, Catalog #6070 Component Part #6070 for PERPOS 2-in-1 Drill-a canulated, 2 step drill to be used over a K-wire to remove bone prior to the 4.5mm BONE-LOK PLS Implant (LSW-45-3040
Terminated
HTWNone listed
Apr 22, 2010Orthohelix Surgical Designs Inc
Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. Used to drill or cut bone prior to implantation of screws
Terminated
HTWK082574
Mar 5, 2009Intelifuse Inc
InteliFUSE, Drill Bit, 2.00 mm, J-Latch, QTY: 1, REF: DB.200.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1
Terminated
HTWNone listed
Mar 5, 2009Intelifuse Inc
InteliFUSE, Drill Bit, 1.50 mm, J-Latch, QTY: 1, REF: DB.150.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1
Terminated
HTWNone listed
Jan 13, 2009Sterilmed Inc
Drill Bits Model #'s: DEP14043 MIC8053-019 RIC21-0438 RIC21-0439 RIC21-0441 RIC21-0442 RIC71173504 RIC71173505 RIC71631117 SMI21-0445 STR5800-4-125 STR60-13570 SYN03.010.060 SYN03.010.061 SYN03.010.1
Terminated
HTWNone listed
Jan 9, 2007Integra LifeSciences Corp.
BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
Terminated
HTWK990622
Feb 26, 2003Stryker Howmedica Osteonics
T2 4.2mmx130mm Tri Flat Bit
Terminated
HTWNone listed
Feb 26, 2003Stryker Howmedica Osteonics
T2 4.2mmx130mm AO Drill Bit
Terminated
HTWNone listed
Feb 26, 2003Stryker Howmedica Osteonics
T2 3.5x130mm Tri Flat Drill Bit
Terminated
HTWNone listed
Feb 26, 2003Stryker Howmedica Osteonics
T2 3.5x130mm AO Drill Bit
Terminated
HTWNone listed
Feb 26, 2003Stryker Howmedica Osteonics
Gamma Drill Dia. 4.2x300mm
Terminated
HTWNone listed
Feb 26, 2003Stryker Howmedica Osteonics
Gamma AO Drill 5.5x300mm
Terminated
HTWNone listed
Feb 26, 2003Stryker Howmedica Osteonics
Gamma Drill 5.5x300mm
Terminated
HTWNone listed

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