Tornier Flex Shoulder System
- Primary DI
- 03700434021776
- Brand
- Tornier Flex Shoulder System
- Company
- TORNIER
- Model
- DWH143
- Catalog number
- DWH143
- Device description
- Tornier Pyrocarbon Humeral Head
- Published
- 2023-01-10
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
tornier.comProduct Codes#
| Code | Name |
|---|---|
| QKW | Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| QKW | Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| DEN220012 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 03700434021776 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 03700434021776 | 03700434021776 | 3700434021776 |
GMDN Terms#
| Term | Definition |
|---|---|
| Stem-fixed metallic humeral head prosthesis | An implantable artificial substitute for a diseased or injured humeral head. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and designed to be attached to a humeral stem prosthesis and to articulate with the natural glenoid fossa, a glenoid fossa prosthesis, or a humeral head bipolar component as part of a shoulder replacement. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Height | 16 | Millimeter |
| Outer Diameter | 43 | Millimeter |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +330476613500 | order@tornier.com |
Regulatory Flags#
- DUNS number
- 260324876
- Device count
- 1
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 03700386968303 | Aequalis Fracture | MWA302 | MWA302 | 2022-08-08 |
| 03700386915260 | AEQUALIS | DWB151 | 2015-10-16 | |
| 03700386916144 | AEQUALIS REVERSED | DWB935 | 2015-10-16 | |
| 03700386916151 | AEQUALIS REVERSED | DWB936 | 2015-10-16 | |
| 03700386916618 | AEQUALIS REVERSED | DWD002 | 2015-10-16 | |
| 03700386916731 | AEQUALIS REVERSED | DWD069 | 2015-10-16 | |
| 03700386931529 | AEQUALIS REVERSED ADAPTER | DWD863 | 2015-10-16 | |
| 03700386931536 | AEQUALIS REVERSED ADAPTER | DWD864 | 2015-10-16 | |
| 03700386931543 | AEQUALIS REVERSED ADAPTER | DWD865 | 2015-10-16 | |
| 03700386925726 | BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATION | MWJ021 | 2017-04-03 | |
| 03700386955648 | BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATION | MWJ003 | 2016-09-11 | |
| 03700386955655 | BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATION | MWJ004 | 2017-04-03 | |
| 03700386915062 | AEQUALIS GLENOID | DWB001 | 2016-01-28 | |
| 03700386915079 | AEQUALIS GLENOID | DWB002 | 2015-10-16 | |
| 03700386915086 | AEQUALIS GLENOID | DWB003 | 2015-10-16 | |
| 03700386915093 | AEQUALIS GLENOID | DWB005 | 2015-10-16 | |
| 03700386915109 | AEQUALIS GLENOID | DWB006 | 2015-10-16 | |
| 03700386915413 | AEQUALIS GLENOID | DWB210 | 2015-10-16 | |
| 03700386915420 | AEQUALIS GLENOID | DWB211 | 2015-10-16 | |
| 03700386915437 | AEQUALIS GLENOID | DWB212 | 2015-10-16 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 03700434019025 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434019469 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434019544 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434019643 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434019940 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434019988 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434020205 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434020267 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434020366 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434020441 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434020823 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434021301 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434021318 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434021356 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434021387 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434021608 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434021752 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434022162 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700434022421 | Tornier Flex Shoulder System | TORNIER | QKW | 2023-01-10 |
| 03700386999055 | Aequalis Pyrocarbon Humeral Head | TORNIER | QKW | 2023-01-06 |
| 03700386957871 | Flex Shoulder System | TORNIER | QKW | 2023-01-06 |
| 03700386957888 | Flex Shoulder System | TORNIER | QKW | 2023-01-06 |
| 03700386957895 | Flex Shoulder System | TORNIER | QKW | 2023-01-06 |
| 03700386957901 | Flex Shoulder System | TORNIER | QKW | 2023-01-06 |
| 03700386957918 | Flex Shoulder System | TORNIER | QKW | 2023-01-06 |
| 03700386957925 | Flex Shoulder System | TORNIER | QKW | 2023-01-06 |
| 03700386957932 | Flex Shoulder System | TORNIER | QKW | 2023-01-06 |
| 03700386957949 | Flex Shoulder System | TORNIER | QKW | 2023-01-06 |
| 03700386957970 | Flex Shoulder System | TORNIER | QKW | 2023-01-06 |
| 03700386987991 | Flex Shoulder System | TORNIER | QKW | 2023-01-06 |