Identity
- Trade Name
- PROMOS FDA UDI
- Generic Name
- Stem-fixed metallic humeral head prosthesis FDA UDI
- Device Name
- PROMOS HUMERAL HEAD R26/+7 FDA UDI
- Model / Reference
- 75006692 FDA UDI
- Description
- PROMOS HUMERAL HEAD R26/+7 FDA UDI
Identifiers
- Catalog Number
- 75006692 FDA UDI
- Primary DI / UDI-DI
- 07611996037838 FDA UDI
- 510(k) Number
- K032126 FDA UDI
- FDA Product Code
- HSD FDA UDI
- GMDN Term
- Stem-fixed metallic humeral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 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: Stem-fixed metallic humeral head prosthesis
Promos by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Stem-fixed metallic humeral head prosthesis.
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Cleared under the same submission
K032126 also covers:
- PROMOS — Smith & Nephew, Inc.
- PROMOS — Smith & Nephew, Inc.
- PROMOS — Smith & Nephew, Inc.
- PROMOS — Smith & Nephew, Inc.
- PROMOS — Smith & Nephew, Inc.
- PROMOS — Smith & Nephew, Inc.
- PROMOS — Smith & Nephew, Inc.
- PROMOS — Smith & Nephew, Inc.
- PROMOS — Smith & Nephew, Inc.
- PROMOS — Smith & Nephew, Inc.
- PROMOS — Smith & Nephew, Inc.
- PROMOS — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 5c01b23e-c71a-490a-886e-45e8eeff7154 36 fields · synced Jun 8, 2026