Identity
- Trade Name
- HUMERIS 135 FDA UDI
- Generic Name
- Polyethylene reverse shoulder prosthesis cup FDA UDI
- Device Name
- HUMERAL CUP ECCENTRIC SYMMETRIC MOBILITY PE/TA6V Ø36+6 / TAPER Ø10 FDA UDI
- Model / Reference
- 323-0606 FDA UDI
- Description
- HUMERAL CUP ECCENTRIC SYMMETRIC MOBILITY PE/TA6V Ø36+6 / TAPER Ø10 FDA UDI
Identifiers
- Catalog Number
- 323-0606 FDA UDI
- Primary DI / UDI-DI
- 03701037310212 FDA UDI
- 510(k) Number
- K222936 FDA UDI
- FDA Product Code
- PHX FDA UDIKWT FDA UDIHSD FDA UDI
- GMDN Term
- Polyethylene reverse shoulder prosthesis cup FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3650 FDA UDI888.3690 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyethylene reverse shoulder prosthesis cup
Humeris 135 by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polyethylene reverse shoulder prosthesis cup.
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Cleared under the same submission
K222936 also covers:
- HUMERIS 135 — FX SOLUTIONS
- HUMERIS 135 — FX SOLUTIONS
- HUMERIS 135 — FX SOLUTIONS
- HUMERIS 135 — FX SOLUTIONS
- HUMERIS 135 — FX SOLUTIONS
- HUMERIS 135 — FX SOLUTIONS
- HUMERIS 135 — FX SOLUTIONS
- HUMERIS 135 — FX SOLUTIONS
- HUMERIS 135 — FX SOLUTIONS
- HUMERIS 135 — FX SOLUTIONS
- HUMERIS 135 — FX SOLUTIONS
- HUMERIS 135 — FX SOLUTIONS
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
- Fx Solutions
Sources (1)
- FDA UDI 17c07dae-08b4-4871-abdd-e05a658e675b 35 fields · synced Jun 8, 2026