Ghajar Guide Twist Drill
FDA 510(k) K875018 · Neurodynamics, Inc.
510(k) numberK875018
Submission
- Device name
- Ghajar Guide Twist Drill
- Applicant
- Neurodynamics, Inc.
New York, NY, US - Received
- December 4, 1987
- Decision date
- January 28, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code HBG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252696 | LegacyHBG · Traditional | Phasor Health, LLC | 11/21/2025SE |
| K153587 | Taps for Resorbable ScrewsHBG · Traditional | Synthes (USA) Products, LLC | 01/18/2017SE |
| K162884 | SpineGuard DSG Zavation Screw SystemHBG · Traditional | Spineguard S.A. | 01/12/2017SE |
| K160129 | MRII Cranial Drill and AccessoriesHBG · Special | Mri Interventions, Inc. | 03/26/2016SE |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG · Special | Mri Interventions, Inc. | 07/08/2015SE |
| K122456 | Mrii Crainial DrillHBG · Traditional | Mri Interventions, Inc. | 03/22/2013SE |
| K022712 | Hand Drill, Model 11-9901-7HBG · Traditional | Medical Design, LLC | 11/12/2002SE |
| K022370 | Framelock; Framelock AccessoriesHBG · Traditional | Medtronic Xomed, Inc. | 10/18/2002SE |
| K961113 | CNS Interchangeable Bit Cranial DrillHBG · Traditional | Clinical Neuro Systems, LLC | 06/05/1996SE |
| K932402 | Modification to Ghajar Guide Twist DrillHBG · Traditional | Neurodynamics, Inc. | 08/05/1993SE |
More from Neurodynamics, Inc.
Questions and answers
When was Ghajar Guide Twist Drill cleared by the FDA?
Ghajar Guide Twist Drill (K875018) received a 510(k) decision of Substantially Equivalent on January 28, 1988, 55 days after the submission was received.
What is the product code of K875018?
The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.