FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Navigated Pedicle Access Kit
K Number: K191012
·
Decision Aug 7, 2019
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
4
Review Days
113
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Basic Information
- Device Name
- Navigated Pedicle Access Kit
- K Number
- K191012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Izi Medical Products, LLC
- Date Received
- April 16, 2019
- Decision Date
- August 7, 2019
- 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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