Identity
- Trade Name
- REUNION FDA UDI
- Generic Name
- Uncoated shoulder humeral stem prosthesis FDA UDI
- Device Name
- CEMENTED HUMERAL STEM FDA UDI
- Model / Reference
- 5569-C-2010 FDA UDI
- Description
- CEMENTED HUMERAL STEM FDA UDI
Identifiers
- Catalog Number
- 5569-C-2010 FDA UDI
- Primary DI / UDI-DI
- 07613327098235 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- Uncoated shoulder humeral stem 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Uncoated shoulder humeral stem prosthesis
Reunion by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated shoulder humeral stem prosthesis.
- Anatomical Shoulder™ — Zimmer, Inc. · Class II
- Humelock II Cemented Shoulder System — FX SOLUTIONS · Class II
- Bigliani/Flatow® — Zimmer, Inc. · Class II
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Anatomical Shoulder™ — Zimmer, Inc. · Class II
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- SMR System — Limacorporate · Class II
- Arthrex® — Arthrex, Inc. · Class II
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
- Stryker Corp.
Sources (1)
- FDA UDI 34112fbd-3e40-4aa8-bf9f-77bbc5e0c35c 35 fields · synced Jun 8, 2026