FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
K Number: K090850
·
Decision Jul 30, 2009
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
8
Review Days
122
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Basic Information
- Device Name
- ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
- K Number
- K090850
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apatech , Ltd.
- Date Received
- March 30, 2009
- Decision Date
- July 30, 2009
- Product Code
- LYC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
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Other Clearances by Apatech , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K082575 | ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES | Nov 25, 2008 | Substantially Equivalent |
| K081979 | ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE | Nov 6, 2008 | Substantially Equivalent |
| K082073 | ACTIFUSE FLOW BONE GRAFT SUBSTITUTE | Sep 11, 2008 | Substantially Equivalent |
| K080736 | ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE | Apr 16, 2008 | Substantially Equivalent |
| K071206 | ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE | May 31, 2007 | Substantially Equivalent |
| K040082 | PORE-SI BONE GRAFT SUBSTITUTE | Aug 4, 2004 | Substantially Equivalent |
| K033722 | APAPORE BONE GRAFT SUBSTITUTE | May 7, 2004 | Substantially Equivalent |