FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KIVA VCF TREATMENT SYSTEM
K Number: K141141
·
Decision Aug 14, 2014
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
107
Applicant Total
8
Review Days
104
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Basic Information
- Device Name
- KIVA VCF TREATMENT SYSTEM
- K Number
- K141141
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Benvenue Medical, Inc.
- Date Received
- May 2, 2014
- Decision Date
- August 14, 2014
- 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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| K132817 | KIVA VCF TREATMENT SYSTEM | Jan 24, 2014 | Substantially Equivalent |
| K070293 | BENVENUE VCF OSTEO COIL SYSTEM | Jul 10, 2007 | Substantially Equivalent |