FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
MODIFICATION TO MBCP
K Number: K043005
·
Decision May 3, 2005
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
8
Review Days
183
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Basic Information
- Device Name
- MODIFICATION TO MBCP
- K Number
- K043005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomatlante
- Date Received
- November 1, 2004
- Decision Date
- May 3, 2005
- Product Code
- MQV
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
| K093122 | MBCP+ | Mar 15, 2010 | Substantially Equivalent |
| K071121 | TRIBONE 80 | Sep 11, 2007 | Substantially Equivalent |
| K063527 | MBCP+ | Jul 30, 2007 | Substantially Equivalent |
| K060732 | MBCP GEL | Jun 2, 2006 | Substantially Equivalent |
| K051774 | MBCP | Jan 20, 2006 | Substantially Equivalent |
| K051885 | MBCP | Sep 16, 2005 | Substantially Equivalent |
| K032268 | MBCP | Dec 11, 2003 | Substantially Equivalent |