FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
DASH HIP
K Number: K110021
·
Decision Oct 18, 2011
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
404
Applicant Total
24
Review Days
288
Basic Information
- Device Name
- DASH HIP
- K Number
- K110021
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BRAINLAB, AG
- Date Received
- January 3, 2011
- Decision Date
- October 18, 2011
- Product Code
- OLO
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OLO), ordered by most recent decision date.
TMINI Miniature Robotic System
FDA 510(k)
FDA Class 2
·Neurology
SPINEART Navigation Instrument System
FDA 510(k)
FDA Class 2
·Neurology
Stealth Spine Clamps; ModuLeX Shank Mounts
FDA 510(k)
FDA Class 2
·Neurology
Paradigm System
FDA 510(k)
FDA Class 2
·Neurology
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
FDA 510(k)
FDA Class 2
·Neurology
OTS Hip
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by BRAINLAB, AG
| K Number | Device Name | ||
|---|---|---|---|
| K132763 | ADVANCED VIEWER | Feb 28, 2014 | Substantially Equivalent |
| K103246 | IPLAN RT | Mar 16, 2011 | Substantially Equivalent |
| K100038 | DISPOSABLE REFLECTIVE MARKER SPHERES | Jul 14, 2010 | Substantially Equivalent |
| K080608 | DIGITAL LIGHTBOX | Apr 17, 2008 | Substantially Equivalent |
| K062358 | MODIFICATION TO VECTORVISION TRAUMA | Jan 17, 2007 | Substantially Equivalent |
| K063028 | VECTORVISION HIP SR | Dec 12, 2006 | Substantially Equivalent |
| K052966 | CI KNEE, CI MI TKR | Feb 13, 2006 | Substantially Equivalent |
| K053127 | IPLAN | Feb 9, 2006 | Substantially Equivalent |
| K041703 | IPLAN! | Oct 22, 2004 | Substantially Equivalent |
| K040931 | PATXFER RT | Jul 22, 2004 | Substantially Equivalent |