FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
K Number: K100314
·
Decision Mar 31, 2010
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
165
Review Days
55
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Basic Information
- Device Name
- IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
- K Number
- K100314
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International S.A.
- Date Received
- February 4, 2010
- Decision Date
- March 31, 2010
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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