FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Humelock II Reversible Shoulder System
K Number: K150488
·
Decision Nov 13, 2015
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
203
Applicant Total
8
Review Days
261
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Humelock II Reversible Shoulder System
- K Number
- K150488
- 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
- February 25, 2015
- Decision Date
- November 13, 2015
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PHX), ordered by most recent decision date.
Augment Off-Axis Instrument System
FDA 510(k)
FDA Class 2
·Orthopedic
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
MSS - Humeral reverse liners extension
FDA 510(k)
FDA Class 2
·Orthopedic
Veritas Reverse Total Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
FDA 510(k)
FDA Class 2
·Orthopedic
Equinoxe® Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| 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 |