FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Prime BIOFOAM® Multi-Hole Shells
K Number: K201157
·
Decision Aug 24, 2021
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
12
Applicant Total
37
Review Days
481
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Basic Information
- Device Name
- Prime BIOFOAM® Multi-Hole Shells
- K Number
- K201157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microport Orthopedics, Inc.
- Date Received
- April 30, 2020
- Decision Date
- August 24, 2021
- Product Code
- MBL
- 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 |
|---|---|---|---|
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | FDA class 2 | Orthopedic |
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