FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SPINE & TRAUMA ICT
K Number: K083310
·
Decision Apr 1, 2009
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
404
Applicant Total
61
Review Days
142
Basic Information
- Device Name
- SPINE & TRAUMA ICT
- K Number
- K083310
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BRAINLAB AG
- Date Received
- November 10, 2008
- Decision Date
- April 1, 2009
- 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 |
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| K120789 | EXACTRAC X-RAY X-RAY | Aug 14, 2012 | Substantially Equivalent |
| K120520 | EXACTRAC ROBOTICS NOVALIS ROBOTICS | Jun 29, 2012 | Substantially Equivalent |
| K113732 | IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) | May 7, 2012 | Substantially Equivalent |
| K110204 | BRAINLAB TRAUMA | Aug 5, 2011 | Substantially Equivalent |
| K101627 | IPLAN | Jun 3, 2011 | Substantially Equivalent |