FDA Registration
Active
🇺🇸 United States
Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial Standard Thickness +3mm Taper Offset 40mm Diameter
Reg #: 3011015572
·
FEI: 3011015572
·
Expires 2025
Products
4
Proprietary Names
55
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- INCIPIO DEVICES
- Registration Number
- 3011015572
- FEI Number
- 3011015572
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3650 West 200 North
- City
- Huntington
- State
- IN
- ZIP
- 46750
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181611
Owner / Operator
- Firm Name
- Incipio Devices
- Operator Number
- 10047511
- Address
- 3650 W 200 N
- City
- Huntington
- State
- IN
- Postal Code
- 46750
- Country
- US
- Correspondent
- Troy Johnson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2018-12-20 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2018-12-20 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2018-12-20 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2018-12-20 |
Proprietary Names
Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial Standard Thickness +3mm Taper Offset 40mm Diameter
Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +6mm Taper Offset 40mm Diameter Co-Cr-Mo
Comprehensive Versa-Dial Reverse Shoulder System, +6mm Lateral Offset 40mm Diameter, Ti-6Al-4V`
Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +0mm Taper Offset 40mm Diameter Co-Cr-Mo
Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +10mm thickness +6mm Taper Offset 40mm Diameter
Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +0mm Taper Offset 40mm Diameter Ti-6Al-4V
Comprehensive Reverse Shoulder System Bearing Trial Standard 40mm Diameter
Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +3mm Taper Offset 40mm Diameter Co-Cr-Mo
Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +6mm Taper Offset 40mm Diameter Ti-6Al-4V
Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +0mm Taper Offset 40mm Diameter Co-Cr-MO
Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +3mm Taper Offset 40mm Diameter Co-Cr-Mo
Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial Standard Thickness +6mm Taper Offset 40mm Diameter
Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +6mm Taper Offset 40mm Diameter Ti-6Al-4V
Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +10mm thickness +0mm Taper Offset 40mm Diameter
Comprehensive Reverse Prolong Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 36mm Diameter
Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +6mm Taper Offset 40mm Diameter Co-Cr-Mo
Comprehensive Versa-Dial Reverse Shoulder System - Glenosphere Trial Standard Offset, +6mm 40mm Diameter
Comprehensive Reverse Shoulder System Bearing Trial +3mm Retentive Thickness 36mm Diameter
Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter40mm Diameter
Comprehensive Reverse Prolong Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 40mm Diameter
Comprehensive Versa-Dial Reverse Shoulder System, Standard, 40mm Diameter Co-Cr-Mo
Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +3mm Taper Offset 40mm Diameter Ti-^Al-4V
Comprehensive Reverse Shoulder System Bearing Trial +3mm Retentive Thickness 40mm Diameter
Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +5mm thickness +0mm Taper Offset 40mm Diameter
Comprehensive Versa-Dial Reverse Shoulder System - Glenosphere Trial Standard Offset 40mm Diameter
Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing Standard 40mm Diameter
Comprehensive Versa-Dial Reverse Shoulder System, +6mm Lateral Offset 40mm Diameter, Co-Cr-Mo
Comprehensive Reverse Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter40mm Diameter
Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +0mm Taper Offset 40mm Diameter Ti-6Al-4V
Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +5mm thickness +3mm Taper Offset 40mm Diameter
Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 36mm Diameter
Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +3mm Taper Offset 40mm Diameter Co-Cr-Mo
Comprehensive Versa-Dial Reverse Shoulder System, +3mm Lateral Offset 40mm Diameter, Ti-6Al-4V
Comprehensive Reverse Shoulder System Prolong Highly Crosslinked Polyethylene Bearing Standard 36mm Diameter
Comprehensive Versa-Dial Reverse Shoulder System, +3mm Lateral Offset 40mm Diameter, Co-Cr-Mo
Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +3mm Taper Offset 40mm Diameter Ti-6Al-4V
Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +3mm Taper Offset 40mm Diameter Ti-6Al-4V
Comprehensive Versa-Dial Reverse Shoulder System, Standard, Ti-6Al-4V, 40mm Diameter
Comprehensive Reverse Prolong Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter 36mm Diameter
Comprehensive Reverse Shoulder System Bearing Trial Standard 36mm Diameter
Comprehensive Versa-Dial Reverse Shoulder System - Glenosphere Trial Standard Offset, +3mm Lateral Offset 40mm Diameter
Comprehensive Reverse
Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +10mm thickness +3mm Taper Offset 40mm Diameter
Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +5mm thickness +6mm Taper Offset 40mm Diameter
Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +6mm Taper Offset 40mm Diameter Co-Cr-Mo
Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +0mm Taper Offset 40mm Diameter Ti-6Al-4V
Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter 36mm Diameter
Comprehensive Reverse Shoulder System Bearing Trial +3mm Thickness 40mm Diameter
Comprehensive Reverse Shoulder System Mini Humeral Tray +10 Thickness +0mm Taper Offset 40mm Diameter Co-Cr-Mo
Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing Standard 36mm Diameter
Comprehensive Reverse Shoulder System Bearing Trial +3mm Thickness 36mm Diameter
Comprehensive Reverse Shoulder System - Mini Humeral Tray Trial +0mm Taper Offset 40mm Diameter
Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 40mm Diameter
Comprehensive Reverse Prolong Highly Crosslinked Polyethylene Bearing Standard 40mm Diameter
Comprehensive Reverse Shoulder System Mini Humeral Tray +5 Thickness +6mm Taper Offset 40mm Diameter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)