FDA 510(k) Applications for Medical Device Product Code "HBG"
(Drills, Burrs, Trephines & Accessories (Manual))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K961113 | CLINICAL NEURO SYSTEMS LLC. | CNS INTERCHANGEABLE BIT CRANIAL DRILL | 06/05/1996 |
| K022712 | MEDICAL DESIGN LLC. | HAND DRILL, MODEL 11-9901-7 | 11/12/2002 |
| K022370 | MEDTRONIC XOMED, INC. | FRAMELOCK; FRAMELOCK ACCESSORIES | 10/18/2002 |
| K122456 | MRI INTERVENTIONS, INC. | MRII CRAINIAL DRILL | 03/22/2013 |
| K160129 | MRI INTERVENTIONS, INC. | MRII Cranial Drill and Accessories | 03/26/2016 |
| K151536 | MRI INTERVENTIONS, INC. | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | 07/08/2015 |
| K162884 | SPINEGUARD,S.A. | SpineGuard DSG Zavation Screw System | 01/12/2017 |
| K153587 | SYNTHES (USA) PRODUCTS LLC | Taps for Resorbable Screws | 01/18/2017 |
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