FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYBONE
K Number: K070012
·
Decision Dec 27, 2007
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
40
Applicant Total
4
Review Days
358
Basic Information
- Device Name
- POLYBONE
- K Number
- K070012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5300
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KYUNGWON MEDICAL CO., LTD.
- Date Received
- January 3, 2007
- Decision Date
- December 27, 2007
- 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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