Identity
- Trade Name
- PROMOS FDA UDI
- Generic Name
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
- Device Name
- PROMOS GLENOID 1-26 CEMENTED FDA UDI
- Model / Reference
- 75006696 FDA UDI
- Description
- PROMOS GLENOID 1-26 CEMENTED FDA UDI
Identifiers
- Catalog Number
- 75006696 FDA UDI
- Primary DI / UDI-DI
- 07611996037166 FDA UDI
- 510(k) Number
- K032126 FDA UDI
- FDA Product Code
- HSD FDA UDI
- GMDN Term
- Shoulder glenoid fossa prosthesis, prefabricated 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: Shoulder glenoid fossa prosthesis, prefabricated
Promos by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Shoulder glenoid fossa prosthesis, prefabricated.
- PRIMA TT Glenoid — Limacorporate · Class II
- AEQUALIS REVERSED II — TORNIER, INC. · Class II
- INHANCE — DEPUY (IRELAND) · Class II
- TITAN™ — Ascension Orthopedics, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- Full Wedge Lateralized and Augmented Baseplates — FX SOLUTIONS · Class II
- SMR System — Limacorporate · Class II
- SMR Metal Back — Limacorporate · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI a8b940c7-dc3c-4945-9425-2a763f9f641b 36 fields · synced Jun 8, 2026