FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
K Number: K080547
·
Decision May 23, 2008
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
18
Review Days
85
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Basic Information
- Device Name
- ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
- K Number
- K080547
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap Implant System, Inc.
- Date Received
- February 28, 2008
- Decision Date
- May 23, 2008
- 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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