DISPOSABLE REFLECTIVE MARKER SPHERES
FDA 510(k) clearance K100038 · decided 2010-07-14
Clearance details
- K-number
- K100038
- Device name
- DISPOSABLE REFLECTIVE MARKER SPHERES
- Applicant
- Brainlab AG
- Decision
- Substantially Equivalent
- Date received
- 2010-01-07
- Decision date
- 2010-07-14
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Feldkirchen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. recall (Z-2084-2015) | Northern Digital Inc. | 2015-07-16 |
| NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. P recall (Z-2093-2015) | Northern Digital Inc. | 2015-07-16 |