FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
CarboClear Navigated Instruments
K Number: K201251
·
Decision Aug 5, 2020
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
404
Applicant Total
17
Review Days
86
Basic Information
- Device Name
- CarboClear Navigated Instruments
- K Number
- K201251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CarboFix Orthopedics Ltd.
- Date Received
- May 11, 2020
- Decision Date
- August 5, 2020
- 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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