Identity
- Trade Name
- Aequalis™ Fx2 FDA UDI
- Generic Name
- Total reverse shoulder prosthesis FDA UDI
- Model / Reference
- DWK266B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700386957055 FDA UDI
- 510(k) Number
- K152966 FDA UDI
- FDA Product Code
- HSD FDA UDIPHX FDA UDIKWS 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
- Not 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
- Outer Diameter — 36 Millimeter FDA UDIAngle — 12.5 degree FDA UDI
Aequalis™ Fx2 by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 59b0a966-1b55-4c6e-a823-3849c1faaf43 36 fields · synced May 31, 2026