FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Comprehensive Nano Stemless Shoulder
K Number: K182516
·
Decision Apr 22, 2019
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
18
Applicant Total
93
Review Days
221
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Basic Information
- Device Name
- Comprehensive Nano Stemless Shoulder
- K Number
- K182516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Manufacturing Corp
- Date Received
- September 13, 2018
- Decision Date
- April 22, 2019
- Product Code
- PKC
- 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 |
|---|---|---|---|
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PKC), ordered by most recent decision date.
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