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)
Top companies in HTW
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 0 | 60 |
| Stryker Howmedica Osteonics | 0 | 8 |
| Exactech, Inc. | 0 | 6 |
| Flower Orthopedics Corporation | 0 | 4 |
| Waldemar Link GmbH & Co. KG (Mfg Site) | 0 | 4 |
| AAP Implantate Ag | 0 | 2 |
| The Anspach Effort, Inc. | 0 | 2 |
| Biomet, Inc. | 0 | 2 |
| Intelifuse Inc | 0 | 2 |
| Interventional Spine Inc | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Interventional 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 |
HTW | None listed |
| Jan 11, 2012 | Interventional 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 |
HTW | None listed |
| Apr 22, 2010 | Orthohelix 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 |
HTW | K082574 |
| Mar 5, 2009 | Intelifuse 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 |
HTW | None listed |
| Mar 5, 2009 | Intelifuse 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 |
HTW | None listed |
| Jan 13, 2009 | Sterilmed 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 |
HTW | None listed |
| Jan 9, 2007 | Integra LifeSciences Corp. BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. Terminated |
HTW | K990622 |
| Feb 26, 2003 | Stryker Howmedica Osteonics T2 4.2mmx130mm Tri Flat Bit Terminated |
HTW | None listed |
| Feb 26, 2003 | Stryker Howmedica Osteonics T2 4.2mmx130mm AO Drill Bit Terminated |
HTW | None listed |
| Feb 26, 2003 | Stryker Howmedica Osteonics T2 3.5x130mm Tri Flat Drill Bit Terminated |
HTW | None listed |
| Feb 26, 2003 | Stryker Howmedica Osteonics T2 3.5x130mm AO Drill Bit Terminated |
HTW | None listed |
| Feb 26, 2003 | Stryker Howmedica Osteonics Gamma Drill Dia. 4.2x300mm Terminated |
HTW | None listed |
| Feb 26, 2003 | Stryker Howmedica Osteonics Gamma AO Drill 5.5x300mm Terminated |
HTW | None listed |
| Feb 26, 2003 | Stryker Howmedica Osteonics Gamma Drill 5.5x300mm Terminated |
HTW | None listed |
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