FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Exactech Alteon Monobloc Revision Stem
K Number: K181532
·
Decision Sep 4, 2018
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
186
Review Days
85
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Basic Information
- Device Name
- Exactech Alteon Monobloc Revision Stem
- K Number
- K181532
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exactech, Inc.
- Date Received
- June 11, 2018
- Decision Date
- September 4, 2018
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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