FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Humelock Reversed Shoulder
K Number: K162455
·
Decision Jan 17, 2017
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
203
Applicant Total
8
Review Days
137
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Basic Information
- Device Name
- Humelock Reversed Shoulder
- K Number
- K162455
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fx Solutions
- Date Received
- September 2, 2016
- Decision Date
- January 17, 2017
- Product Code
- PHX
- 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 |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | FDA class 2 | Orthopedic |
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Other Clearances by Fx Solutions
| K Number | Device Name | ||
|---|---|---|---|
| K163669 | Humeris Shoulder | May 17, 2017 | Substantially Equivalent |
| K150488 | Humelock II Reversible Shoulder System | Nov 13, 2015 | Substantially Equivalent |
| K143721 | PRCT2 | Aug 27, 2015 | Substantially Equivalent |
| K140071 | HUMELOCK II CEMENTED SHOULDER SYSTEM | Jul 28, 2014 | Substantially Equivalent |
| K130759 | HUMELOCK II CEMENTLESS SHOULDER SYSTEM | Nov 9, 2013 | Substantially Equivalent |
| K123814 | HUMELOCK II CEMENTED SHOULDER SYSTEM | Aug 13, 2013 | Substantially Equivalent |
| K111097 | HUMELOCK CEMENTED SHOULDER PROSTHESIS | Nov 9, 2011 | Substantially Equivalent |