FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYBONE
K Number: K070012
·
Decision Dec 27, 2007
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
43
Applicant Total
4
Review Days
358
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
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
- Kyung Won 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXP), ordered by most recent decision date.
Permatage XT Settable Bone Putty
FDA 510(k)
FDA Class 2
·Neurology
Permatage Flowable, Settable Bone Paste
FDA 510(k)
FDA Class 2
·Neurology
MONTAGE XT Cranial Cement
FDA 510(k)
FDA Class 2
·Neurology
Permatage Settable Bone Putty
FDA 510(k)
FDA Class 2
·Neurology
Montage Flowable Settable, Resorbable Bone Paste
FDA 510(k)
FDA Class 2
·Neurology
MONTAGE-QS Settable, Resorbable Bone Putty
FDA 510(k)
FDA Class 2
·Neurology