Identity
- Trade Name
- Aequalis™ Ascend™ Flex FDA UDI
- Generic Name
- Total reverse shoulder prosthesis FDA UDI
- Model / Reference
- DWF611A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700386944741 FDA UDI
- 510(k) Number
- K122698 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- Total reverse shoulder prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 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
- Length — 88 Millimeter FDA UDIAngle — 127.5 degree FDA UDI
Category: Total reverse shoulder prosthesis
Aequalis™ Ascend™ Flex 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
K122698 also covers:
- Aequalis™ Ascend™ Flex — TORNIER, INC.
- Aequalis™ Ascend™ Flex — TORNIER, INC.
- Aequalis™ Ascend™ Flex — TORNIER, INC.
- Aequalis™ Ascend™ Flex — TORNIER, INC.
- Aequalis™ Ascend™ Flex — TORNIER, INC.
- Aequalis™ Ascend™ Flex — TORNIER, INC.
- Aequalis™ Ascend™ Flex — TORNIER, INC.
- Aequalis™ Ascend™ Flex — TORNIER, INC.
- Aequalis™ Ascend™ Flex — TORNIER, INC.
- Aequalis™ Ascend™ Flex — TORNIER, INC.
- Aequalis™ Ascend™ Flex — TORNIER, INC.
- Aequalis™ Ascend™ Flex — 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 b9082596-0d51-4898-a0c7-276454fbcc6e 35 fields · synced May 30, 2026