FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
INNOVERSE Navigation Instruments
K Number: K241082
·
Decision Jun 14, 2024
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
4
Review Days
56
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Basic Information
- Device Name
- INNOVERSE Navigation Instruments
- K Number
- K241082
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innosys Co., Ltd.
- Date Received
- April 19, 2024
- Decision Date
- June 14, 2024
- 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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