FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
K Number: K031807
·
Decision Jul 2, 2003
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
77
Applicant Total
402
Review Days
21
Basic Information
- Device Name
- SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
- K Number
- K031807
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SYNTHES (USA)
- Date Received
- June 11, 2003
- Decision Date
- July 2, 2003
- Product Code
- DZL
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | FDA class 2 | Dental |
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