FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
TRIBONE 80
K Number: K071121
·
Decision Sep 11, 2007
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
8
Review Days
144
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Basic Information
- Device Name
- TRIBONE 80
- K Number
- K071121
- 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
- April 20, 2007
- Decision Date
- September 11, 2007
- 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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Other Clearances by Biomatlante
| K Number | Device Name | ||
|---|---|---|---|
| K093122 | MBCP+ | Mar 15, 2010 | 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 |
| K043005 | MODIFICATION TO MBCP | May 3, 2005 | Substantially Equivalent |
| K032268 | MBCP | Dec 11, 2003 | Substantially Equivalent |