FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
K Number: K113728
·
Decision Nov 15, 2012
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
30
Applicant Total
4
Review Days
332
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Basic Information
- Device Name
- SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
- K Number
- K113728
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hans Biomed Corp.
- Date Received
- December 19, 2011
- Decision Date
- November 15, 2012
- Product Code
- MBP
- 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 |
|---|---|---|---|
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | FDA class 2 | Orthopedic |
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