LEGACY
FDA 510(k) clearance K252696 · decided 2025-11-21
Clearance details
- K-number
- K252696
- Device name
- LEGACY
- Applicant
- Phasor Health, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-08-27
- Decision date
- 2025-11-21
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HBG
- Device class
- 2
- Regulation number
- 882.4300
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Taps for Resorbable Screws (K153587) | Synthes (USA) Products, LLC | 2017-01-18 |
| SpineGuard DSG Zavation Screw System (K162884) | Spineguard S.A. | 2017-01-12 |
| MRII Cranial Drill and Accessories (K160129) | Mri Interventions, Inc. | 2016-03-26 |
| SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (K151536) | Mri Interventions, Inc. | 2015-07-08 |
| MRII CRAINIAL DRILL (K122456) | Mri Interventions, Inc. | 2013-03-22 |
| HAND DRILL, MODEL 11-9901-7 (K022712) | Medical Design, LLC | 2002-11-12 |
| FRAMELOCK; FRAMELOCK ACCESSORIES (K022370) | Medtronic Xomed, Inc. | 2002-10-18 |
| CNS INTERCHANGEABLE BIT CRANIAL DRILL (K961113) | Clinical Neuro Systems, LLC | 1996-06-05 |
| MODIFICATION TO GHAJAR GUIDE TWIST DRILL (K932402) | Neurodynamics, Inc. | 1993-08-05 |
| PS MEDICAL VENTRICULOSTOMY KIT (K915546) | Pudenz-Schulte Medical Research Corp. | 1991-12-30 |
| PS MEDICAL CRANIAL HAND DRILL (K904283) | Pudenz-Schulte Medical Research Corp. | 1990-10-03 |
| MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT (K902818) | Ruggles Corp. | 1990-09-20 |
Recalls involving this device
No recalls on record reference this clearance.