Product code HBG
- Device name
- Drills, Burrs, Trephines & Accessories (Manual)
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4300
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252696 | LEGACY | Phasor Health, LLC | 2025-11-21 |
| K153587 | Taps for Resorbable Screws | Synthes (USA) Products, LLC | 2017-01-18 |
| K162884 | SpineGuard DSG Zavation Screw System | Spineguard S.A. | 2017-01-12 |
| K160129 | MRII Cranial Drill and Accessories | Mri Interventions, Inc. | 2016-03-26 |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | Mri Interventions, Inc. | 2015-07-08 |
| K122456 | MRII CRAINIAL DRILL | Mri Interventions, Inc. | 2013-03-22 |
| K022712 | HAND DRILL, MODEL 11-9901-7 | Medical Design, LLC | 2002-11-12 |
| K022370 | FRAMELOCK; FRAMELOCK ACCESSORIES | Medtronic Xomed, Inc. | 2002-10-18 |
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL | Clinical Neuro Systems, LLC | 1996-06-05 |
| K932402 | MODIFICATION TO GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | 1993-08-05 |
| K915546 | PS MEDICAL VENTRICULOSTOMY KIT | Pudenz-Schulte Medical Research Corp. | 1991-12-30 |
| K904283 | PS MEDICAL CRANIAL HAND DRILL | Pudenz-Schulte Medical Research Corp. | 1990-10-03 |
| K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | Ruggles Corp. | 1990-09-20 |
| K892531 | NEUROSURGICAL DRILLS: STILLE, HUDSON | Zinnanti Surgical Instruments, Inc. | 1989-05-05 |
| K875018 | GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | 1988-01-28 |
| K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | Solway, Inc. | 1987-12-30 |
| K862160 | CAMINO HAND DRILL - MODEL 030 | Camino Laboratories, Inc. | 1986-07-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10381780126751 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127123 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127116 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127109 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127093 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127086 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127079 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127062 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127055 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127048 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780126744 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780126768 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780126775 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780126782 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780126836 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780126874 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780126904 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780126911 | Integra® Ruggles®-Redmond™ | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127031 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780126928 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780126935 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780127024 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780127017 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780127000 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780126997 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780126980 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780126973 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780126966 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780126959 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780126942 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |