FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMI-ARC SURGICAL NAVIGATOR
K Number: K013257
·
Decision Oct 30, 2001
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
91
Review Days
29
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Basic Information
- Device Name
- HEMI-ARC SURGICAL NAVIGATOR
- K Number
- K013257
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nuvasive, Inc.
- Date Received
- October 1, 2001
- Decision Date
- October 30, 2001
- 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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