FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
K Number: K042986
·
Decision Nov 17, 2004
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
402
Review Days
19
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Basic Information
- Device Name
- MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
- K Number
- K042986
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5250
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (Usa)
- Date Received
- October 29, 2004
- Decision Date
- November 17, 2004
- Product Code
- GXR
- 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 |
|---|---|---|---|
| GXR | Cover, Burr Hole | FDA class 2 | Neurology |
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