FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
HUMELOCK II CEMENTED SHOULDER SYSTEM
K Number: K123814
·
Decision Aug 13, 2013
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
70
Applicant Total
8
Review Days
244
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Basic Information
- Device Name
- HUMELOCK II CEMENTED SHOULDER SYSTEM
- K Number
- K123814
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3650
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fx Solutions
- Date Received
- December 12, 2012
- Decision Date
- August 13, 2013
- Product Code
- KWT
- 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 |
|---|---|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 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 |
| K162455 | Humelock Reversed Shoulder | Jan 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 |
| K111097 | HUMELOCK CEMENTED SHOULDER PROSTHESIS | Nov 9, 2011 | Substantially Equivalent |