FDA 510(k) Applications for Medical Device Product Code "HBE"
(Drills, Burrs, Trephines & Accessories (Simple, Powered))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K170442 | Ad-Tech Medical Instrument Corporation | Cranial Drill Bits and Accessories | 09/07/2017 |
| K130755 | ADEOR MEDICAL AG | HICUT HIGHSPEED INSTRUMENT | 06/27/2014 |
| K191479 | adeor Medical AG | Velocity Alpha Highspeed Surgical Drill System | 04/11/2021 |
| K203739 | Aesculap Inc. | ELAN 4 Electro Motor System | 08/24/2021 |
| K022942 | AESCULAP, INC. | CRANIOCUT | 10/21/2002 |
| K172709 | Aesculap, Inc. | ELAN 4 Electro Motor System Tools | 10/17/2018 |
| K182527 | Aesculap, Inc. | ELAN 4 Tools | 01/19/2019 |
| K183203 | Aesculap, Inc. | ELAN 4 Tools | 08/09/2019 |
| K213072 | Biomet Micofixation | 2.1 x 255mm Drill, 22mm Stop | 08/23/2022 |
| K223199 | Biomet Microfixation | 2.1 x 255mm Drill, 22mm Stop | 11/15/2022 |
| K213208 | Biomet Microfixation | Twist Drills | 12/23/2021 |
| K161704 | BIOTEX, INC. | Phasor Drill | 12/01/2016 |
| K030172 | BRASSELER USA I, L.P. | SMALL HIGH SPEED MOTOR DRILL SYSTEM | 04/03/2003 |
| K153519 | CAREVATURE MEDICAL LTD | DReal | 03/16/2016 |
| K230619 | Hubly Inc. | Hubly Electric Drill (H100) | 05/04/2023 |
| K984035 | KOMET MEDICAL | XK-95 HIGH SPEED MOTOR DRILL SYSTEM | 06/03/1999 |
| K072315 | MEDTRONIC POWERED SURGICAL SOLUTIONS | MIDAS REX CURVED BUR | 09/18/2007 |
| K213454 | Medtronic Powered Surgical Solutions | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm | 11/23/2021 |
| K123270 | MEDTRONIC SOFAMOR DANEK USA, INC. | POWEREASE SYSTEM | 01/11/2013 |
| K182436 | Medtronic Sofamor Danek USA, Inc. | POWEREASE System | 10/04/2018 |
| K121264 | MEDTRONIC SURGICAL TECHNOLOGIES | TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE | 08/27/2012 |
| K081475 | MEDTRONIC XOMED, INC. | ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] | 10/17/2008 |
| K111520 | MEDTRONIC XOMED, INC. | IPC POWEREASE SYSTEM | 10/26/2011 |
| K014060 | MICROAIRE SURGICAL INSTRUMENTS, INC. | MICROAIRE 1000E SYSTEM | 03/05/2002 |
| K132436 | MRI INTERVENTIONS, INC. | VARIOGUIDE DRILL KIT | 03/20/2014 |
| K202120 | Nakanishi Inc. | P300 Attachment | 10/22/2021 |
| K162542 | OSTEOMED | OsteoMed PINNACLE Driver | 05/19/2017 |
| K190172 | Stryker | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | 06/14/2019 |
| K143320 | STRYKER CORP. | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | 04/23/2015 |
| K143399 | STRYKER CORP. | Stryker Footed Attachments and Cutting Accessories | 05/08/2015 |
| K210377 | Stryker Corporation | Stryker iBur hubs and cutting accessories | 06/30/2021 |
| K191049 | Stryker Corporation | Stryker MIS and Footed Attachments | 06/18/2019 |
| K143540 | STRYKER CORPORATION | Stryker MIS Attachments and Cutting Accessories | 05/01/2015 |
| K070876 | STRYKER CRANIOMAXILLOFACIAL | STRYKER TWIST DRILLS | 04/27/2007 |
| K032303 | STRYKER INSTRUMENTS | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | 01/16/2004 |
| K040076 | THE ANSPACH EFFORT, INC. | ANSPACH ADVANCED MICRO SAW ATTACHMENTS | 03/15/2004 |
| K002903 | THE ANSPACH EFFORT, INC. | ANSPACH ANGLED MICRONOSE ATTACHMENT | 10/24/2000 |
| K050628 | THE ANSPACH EFFORT, INC. | ANSPACH COUPLER | 04/07/2005 |
| K113476 | THE ANSPACH EFFORT, INC. | ANSPACH DISSECTION TOOLS | 12/16/2011 |
| K183545 | The Anspach Effort, Inc. | Anspach Helix Dissection Tools | 07/19/2019 |
| K042783 | THE ANSPACH EFFORT, INC. | ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM | 12/17/2004 |
| K080802 | THE ANSPACH EFFORT, INC. | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL | 04/30/2008 |
| K062842 | WALTER LORENZ SURGICAL, INC. | TWIST DRILL | 12/04/2006 |
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