FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMNS MEDACTA NAVIGATION SYSTEM
K Number: K083872
·
Decision Jan 15, 2009
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
165
Review Days
17
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Basic Information
- Device Name
- IMNS MEDACTA NAVIGATION SYSTEM
- K Number
- K083872
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International S.A.
- Date Received
- December 29, 2008
- Decision Date
- January 15, 2009
- Product Code
- OLO
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- Y
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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