Identity
- Trade Name
- FLEX SHOULDER SYSTEM FDA UDI
- Generic Name
- Stem-fixed metallic humeral head prosthesis FDA UDI
- Model / Reference
- DWG157 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700386942884 FDA UDI
- 510(k) Number
- K122698 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- Stem-fixed metallic humeral head 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
- Height — 24 Millimeter FDA UDIOuter Diameter — 55.4 Millimeter FDA UDI
Category: Stem-fixed metallic humeral head prosthesis
Flex Shoulder System by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stem-fixed metallic humeral head prosthesis.
- MRS — Howmedica Osteonics Corp. · Class II
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC. · Class II
- Equinoxe — Exactech, Inc. · Class II
- Anatomical Shoulder™ Domelock® — Zimmer, Inc. · Class II
- GLOBAL AP — DEPUY ORTHOPAEDICS, INC. · Class II
- REUNION — Stryker Corp. · Class II
- Anatomical Shoulder™ Domelock® — Zimmer, Inc. · Class II
- INTEGRATED SHOULDER SYSTEM — Biomet Orthopedics, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tornier, Inc.
Sources (1)
- FDA UDI 369fc370-fcb7-4262-9cd2-0a049755b867 35 fields · synced May 30, 2026