Identity
- Trade Name
- Flex Shoulder System FDA UDI
- Generic Name
- Total reverse shoulder prosthesis FDA UDI
- Model / Reference
- DWF356A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700386955327 FDA UDI
- 510(k) Number
- K151293 FDA UDI
- FDA Product Code
- HSD FDA UDIKWS FDA UDIPHX FDA UDI
- GMDN Term
- Total reverse shoulder prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI888.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 17.5 degree FDA UDIOuter Diameter — 33 Millimeter FDA UDI
Category: Total reverse shoulder prosthesis
Flex Shoulder System by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total reverse shoulder prosthesis.
- Anatomical Shoulder# — Zimmer, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Shoulder Innovations Inset Reverse Total Shoulder — SHOULDER INNOVATIONS, Inc · Class II
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DELTA XTEND — DEPUY (IRELAND) · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Cleared under the same submission
K151293 also covers:
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
- Flex Shoulder System — TORNIER, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tornier, Inc.
Sources (1)
- FDA UDI 5d042553-0f3d-4f90-98c4-ff81c84ec4ff 35 fields · synced May 31, 2026