FDA Product Code
FDA Product Code HBE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4310
510(k) Clearances — 65 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) | Surgify Medical OY | 2026-03-26 | Traditional | PDF ↗ |
| K250815 | Hubly Drill (H100) | Hubly, Inc. | 2025-11-06 | Traditional | PDF ↗ |
| K252060 | GREEN | Phasor Health, LLC | 2025-10-31 | Traditional | PDF ↗ |
| K252662 | UniBur | Nakanishi, Inc. | 2025-09-19 | Traditional | PDF ↗ |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) | Surgify Medical OY | 2025-06-04 | Special | PDF ↗ |
| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) | Surgify Medical OY | 2025-03-13 | Special | PDF ↗ |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R | Stryker Instruments | 2025-03-11 | Special | PDF ↗ |
| K232684 | Surgify Halo | Surgify Medical OY | 2023-11-29 | Traditional | PDF ↗ |
| K230619 | Hubly Electric Drill (H100) | Hubly, Inc. | 2023-05-04 | Traditional | PDF ↗ |
| K223199 | 2.1 x 255mm Drill, 22mm Stop | Biomet Microfixation | 2022-11-15 | Special | PDF ↗ |
| K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | 2022-08-23 | Traditional | PDF ↗ |
| K213208 | Twist Drills | Biomet Microfixation | 2021-12-23 | Traditional | PDF ↗ |
| K213454 | 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 | Medtronic Powered Surgical Solutions | 2021-11-23 | Special | PDF ↗ |
| K202120 | P300 Attachment | Nakanishi, Inc. | 2021-10-22 | Traditional | PDF ↗ |
| K203739 | ELAN 4 Electro Motor System | Aesculap, Inc. | 2021-08-24 | Traditional | PDF ↗ |
| K210377 | Stryker iBur hubs and cutting accessories | Stryker Corporation | 2021-06-30 | Traditional | PDF ↗ |
| K191479 | Velocity Alpha Highspeed Surgical Drill System | Adeor Medical AG | 2021-04-11 | Traditional | PDF ↗ |
| K183203 | ELAN 4 Tools | Aesculap, Inc. | 2019-08-09 | Traditional | PDF ↗ |
| K183545 | Anspach Helix Dissection Tools | The Anspach Effort, Inc. | 2019-07-19 | Traditional | PDF ↗ |
| K191049 | Stryker MIS and Footed Attachments | Stryker Corporation | 2019-06-18 | Traditional | PDF ↗ |
| K190172 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Stryker | 2019-06-14 | Traditional | PDF ↗ |
| K182527 | ELAN 4 Tools | Aesculap, Inc. | 2019-01-19 | Traditional | PDF ↗ |
| K172709 | ELAN 4 Electro Motor System Tools | Aesculap, Inc. | 2018-10-17 | Traditional | PDF ↗ |
| K182436 | POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2018-10-04 | Special | PDF ↗ |
| K170442 | Cranial Drill Bits and Accessories | Ad-Tech Medical Instrument Corporation | 2017-09-07 | Traditional | PDF ↗ |
| K162542 | OsteoMed PINNACLE Driver | Osteomed | 2017-05-19 | Traditional | PDF ↗ |
| K161704 | Phasor Drill | Biotex, Inc. | 2016-12-01 | Traditional | PDF ↗ |
| K153519 | DReal | Carevature Medical, Ltd. | 2016-03-16 | Traditional | PDF ↗ |
| K143399 | Stryker Footed Attachments and Cutting Accessories | Stryker Corp. | 2015-05-08 | Traditional | PDF ↗ |
| K143540 | Stryker MIS Attachments and Cutting Accessories | Stryker Corporation | 2015-05-01 | Traditional | PDF ↗ |
| K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Stryker Corp. | 2015-04-23 | Traditional | PDF ↗ |
| K130755 | HICUT HIGHSPEED INSTRUMENT | Adeor Medical AG | 2014-06-27 | Traditional | PDF ↗ |
| K132436 | VARIOGUIDE DRILL KIT | Mri Interventions, Inc. | 2014-03-20 | Traditional | PDF ↗ |
| K123270 | POWEREASE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2013-01-11 | Traditional | PDF ↗ |
| K121264 | TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE | Medtronic Surgical Technologies | 2012-08-27 | Traditional | PDF ↗ |
| K113476 | ANSPACH DISSECTION TOOLS | The Anspach Effort, Inc. | 2011-12-16 | Special | PDF ↗ |
| K111520 | IPC POWEREASE SYSTEM | Medtronic Xomed, Inc. | 2011-10-26 | Traditional | PDF ↗ |
| K081475 | ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] | Medtronic Xomed, Inc. | 2008-10-17 | Traditional | PDF ↗ |
| K080802 | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL | The Anspach Effort, Inc. | 2008-04-30 | Special | PDF ↗ |
| K072315 | MIDAS REX CURVED BUR | Medtronic Powered Surgical Solutions | 2007-09-18 | Special | PDF ↗ |
| K070876 | STRYKER TWIST DRILLS | Stryker Craniomaxillofacial | 2007-04-27 | Traditional | PDF ↗ |
| K062842 | TWIST DRILL | Walter Lorenz Surgical, Inc. | 2006-12-04 | Traditional | PDF ↗ |
| K050628 | ANSPACH COUPLER | The Anspach Effort, Inc. | 2005-04-07 | Traditional | PDF ↗ |
| K042783 | ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM | The Anspach Effort, Inc. | 2004-12-17 | Traditional | PDF ↗ |
| K040076 | ANSPACH ADVANCED MICRO SAW ATTACHMENTS | The Anspach Effort, Inc. | 2004-03-15 | Traditional | PDF ↗ |
| K032303 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Instruments | 2004-01-16 | Traditional | PDF ↗ |
| K030172 | SMALL HIGH SPEED MOTOR DRILL SYSTEM | Brasseler USA I, L.P. | 2003-04-03 | Traditional | PDF ↗ |
| K022942 | CRANIOCUT | Aesculap, Inc. | 2002-10-21 | Traditional | PDF ↗ |
| K014060 | MICROAIRE 1000E SYSTEM | Microaire Surgical Instruments, Inc. | 2002-03-05 | Traditional | PDF ↗ |
| K002903 | ANSPACH ANGLED MICRONOSE ATTACHMENT | The Anspach Effort, Inc. | 2000-10-24 | Traditional | PDF ↗ |
| K984035 | XK-95 HIGH SPEED MOTOR DRILL SYSTEM | Komet Medical | 1999-06-03 | Traditional | PDF ↗ |
| K943541 | 75K STAIGHT DRILL | Stryker Corp. | 1995-05-18 | Traditional | PDF ↗ |
| K935861 | MEDNEXT BUR | Mednext, Inc. | 1994-05-03 | Traditional | PDF ↗ |
| K930229 | CLINICAL NEURO SYSTEMS CRANIAL DRILL | Clinical Neuro Systems, LLC | 1993-03-16 | Traditional | PDF ↗ |
| K922299 | ZEPPELIN MOTOR DRILL SYSTEM | Von Zeppelin Chirurgische Instrumente GmbH | 1992-10-13 | Traditional | PDF ↗ |
| K911812 | ACRA-CUT WIRE PASS DRILL | Acra Cut, Inc. | 1991-09-10 | Traditional | PDF ↗ |
| K911819 | ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED | Acra Cut, Inc. | 1991-09-10 | Traditional | PDF ↗ |
| K905097 | MICRO-AIRE MODEL NUMBER: MK-426 | Micro Surgical Instruments Corp. | 1990-12-21 | Traditional | PDF ↗ |
| K902703 | CRANIOTOME BLADE OR DRILL BIT | A. Henniss | 1990-11-13 | Traditional | PDF ↗ |
| K903664 | MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL | Micro-Aire Surgical Instruments, Inc. | 1990-09-13 | Traditional | PDF ↗ |
| K900388 | MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES | Midas Rex Pneumatic Tools, Inc. | 1990-05-07 | Traditional | PDF ↗ |
| K881418 | CRANIOTOME BLADE OR NEURO BLADE | Nuell Air Equipment & Hospital Supplies, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K880601 | WIRE PASS DRILL BITS | Nuell Air Equipment & Hospital Supplies, Inc. | 1988-05-06 | Traditional | PDF ↗ |
| K875224 | HUDSON CRANINAL BURRS | Tri-Med, Inc. | 1988-01-28 | Traditional | PDF ↗ |
| K873692 | RAYLOR(TM) DRILL STOP | Cedar Surgical, Inc. | 1987-12-17 | Traditional | PDF ↗ |
Product code HBE · Class II · Neurology. Data: openFDA.