FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
GLOBAL ICON Stemless Shoulder System
K Number: K212683
·
Decision Jan 19, 2022
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
18
Applicant Total
13
Review Days
148
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Basic Information
- Device Name
- GLOBAL ICON Stemless Shoulder System
- K Number
- K212683
- 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
- August 24, 2021
- Decision Date
- January 19, 2022
- 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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SMR Stemless Anatomic
FDA 510(k)
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| 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 |