FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
K Number: K150607
·
Decision Apr 9, 2015
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
107
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
- K Number
- K150607
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osseon, LLC
- Date Received
- March 10, 2015
- Decision Date
- April 9, 2015
- Product Code
- NDN
- 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 |
|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | FDA class 2 | Orthopedic |
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