FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EP Granules BVF
K Number: K180853
·
Decision Aug 6, 2018
Classifications
1
FEI Numbers
234
Registration Numbers
234
Same Product Code
483
Applicant Total
1
Review Days
126
Basic Information
- Device Name
- EP Granules BVF
- K Number
- K180853
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elute, Inc.
- Date Received
- April 2, 2018
- Decision Date
- August 6, 2018
- Product Code
- MQV
- 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 |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | FDA class 2 | Orthopedic |
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