FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CERASORB ORTHO
K Number: K014156
·
Decision Mar 18, 2002
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
10
Review Days
89
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Basic Information
- Device Name
- CERASORB ORTHO
- K Number
- K014156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Curasan AG
- Date Received
- December 19, 2001
- Decision Date
- March 18, 2002
- 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 Curasan AG
| K Number | Device Name | ||
|---|---|---|---|
| K181721 | Ceracell Ortho Foam | Sep 17, 2018 | Substantially Equivalent |
| K160566 | Cerasorb Ortho Foam | Dec 2, 2016 | Substantially Equivalent |
| K111105 | CURASAN OSSEOLIVE DENTAL | Dec 20, 2012 | Substantially Equivalent |
| K103709 | CERACELL DENTAL | Mar 10, 2011 | Substantially Equivalent |
| K102872 | OSBONE DENTAL | Jan 12, 2011 | Substantially Equivalent |
| K100841 | BONEOPTIMIZER | Aug 19, 2010 | Substantially Equivalent |
| K063106 | REVOIS IMPLANT SYSTEM | Jun 11, 2007 | Substantially Equivalent |
| K040216 | CERASORB M ORTHO | Mar 26, 2004 | Substantially Equivalent |
| K031651 | MODIFICATION TO CERASORB ORTHO | Aug 13, 2003 | Substantially Equivalent |