FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
DELTA XTEND(TM) Reverse Shoulder System
K Number: K192855
·
Decision Feb 24, 2020
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
203
Applicant Total
13
Review Days
143
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
- DELTA XTEND(TM) Reverse Shoulder System
- K Number
- K192855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy(Ireland)
- Date Received
- October 4, 2019
- Decision Date
- February 24, 2020
- 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 Depuy(Ireland)
| K Number | Device Name | ||
|---|---|---|---|
| K212683 | GLOBAL ICON Stemless Shoulder System | Jan 19, 2022 | Substantially Equivalent |
| K190344 | DePuy Corail AMT Hip Prosthesis | Nov 1, 2019 | Substantially Equivalent |
| K191779 | Attune Revision LPS Inserts | Oct 8, 2019 | Substantially Equivalent |
| K192448 | Delta Xtend Revers Shoulder System | Oct 4, 2019 | Substantially Equivalent |
| K183077 | Delta Xtend Reverse Shoulder System | May 17, 2019 | Substantially Equivalent |
| K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | Jun 15, 2017 | Substantially Equivalent |
| K160907 | DePuy Actis DuoFix Hip Prosthesis | Jul 19, 2016 | Substantially Equivalent |
| K160700 | ATTUNE Revision Knee System | Jun 10, 2016 | Substantially Equivalent |
| K140881 | DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS | Feb 13, 2015 | Substantially Equivalent |
| K133834 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | Apr 3, 2014 | Substantially Equivalent |