FDA Product Code
FDA Product Code HBG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4300
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252696 | LEGACY | Phasor Health, LLC | 2025-11-21 | Traditional | PDF ↗ |
| K153587 | Taps for Resorbable Screws | Synthes (USA) Products, LLC | 2017-01-18 | Traditional | PDF ↗ |
| K162884 | SpineGuard DSG Zavation Screw System | Spineguard S.A. | 2017-01-12 | Traditional | PDF ↗ |
| K160129 | MRII Cranial Drill and Accessories | Mri Interventions, Inc. | 2016-03-26 | Special | PDF ↗ |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | Mri Interventions, Inc. | 2015-07-08 | Special | PDF ↗ |
| K122456 | MRII CRAINIAL DRILL | Mri Interventions, Inc. | 2013-03-22 | Traditional | PDF ↗ |
| K022712 | HAND DRILL, MODEL 11-9901-7 | Medical Design, LLC | 2002-11-12 | Traditional | PDF ↗ |
| K022370 | FRAMELOCK; FRAMELOCK ACCESSORIES | Medtronic Xomed, Inc. | 2002-10-18 | Traditional | PDF ↗ |
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL | Clinical Neuro Systems, LLC | 1996-06-05 | Traditional | PDF ↗ |
| K932402 | MODIFICATION TO GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | 1993-08-05 | Traditional | PDF ↗ |
| K915546 | PS MEDICAL VENTRICULOSTOMY KIT | Pudenz-Schulte Medical Research Corp. | 1991-12-30 | Traditional | PDF ↗ |
| K904283 | PS MEDICAL CRANIAL HAND DRILL | Pudenz-Schulte Medical Research Corp. | 1990-10-03 | Traditional | PDF ↗ |
| K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | Ruggles Corp. | 1990-09-20 | Traditional | PDF ↗ |
| K892531 | NEUROSURGICAL DRILLS: STILLE, HUDSON | Zinnanti Surgical Instruments, Inc. | 1989-05-05 | Traditional | PDF ↗ |
| K875018 | GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | 1988-01-28 | Traditional | PDF ↗ |
| K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | Solway, Inc. | 1987-12-30 | Traditional | PDF ↗ |
| K862160 | CAMINO HAND DRILL - MODEL 030 | Camino Laboratories, Inc. | 1986-07-18 | Traditional | PDF ↗ |
Product code HBG · Class II · Neurology. Data: openFDA.