FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES (USA) CHRONOS
K Number: K041350
·
Decision Jul 8, 2004
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
43
Applicant Total
402
Review Days
49
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Basic Information
- Device Name
- SYNTHES (USA) CHRONOS
- K Number
- K041350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5300
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (Usa)
- Date Received
- May 20, 2004
- Decision Date
- July 8, 2004
- Product Code
- GXP
- 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 |
|---|---|---|---|
| GXP | Methyl Methacrylate For Cranioplasty | FDA class 2 | Neurology |
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