FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Compress and Mini Compress Anti-Rotation Spindles
K Number: K183553
·
Decision Jan 22, 2019
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
36
Applicant Total
441
Review Days
33
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Basic Information
- Device Name
- Compress and Mini Compress Anti-Rotation Spindles
- K Number
- K183553
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3670
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- December 20, 2018
- Decision Date
- January 22, 2019
- Product Code
- MBF
- 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 |
|---|---|---|---|
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
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