FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
K Number: K113452
·
Decision Feb 17, 2012
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
106
Applicant Total
1
Review Days
88
Basic Information
- Device Name
- ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
- K Number
- K113452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ASCENDX SPINE, INC.
- Date Received
- November 21, 2011
- Decision Date
- February 17, 2012
- 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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