Identity
- Trade Name
- Tahoe Uni Knee System FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- Tibial Insert, UHMWPE, 8, 9mm FDA UDI
- Model / Reference
- 2060-0-0809 FDA UDI
- Description
- Tibial Insert, UHMWPE, 8, 9mm FDA UDI
Identifiers
- Catalog Number
- 2060-0-0809 FDA UDI
- Primary DI / UDI-DI
- 00840286813860 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3520 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
Yes
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: Tibial insert
Tahoe Uni Knee System by Shalby Advanced Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Shalby Advanced Technologies, Inc.
Sources (1)
- FDA UDI f0694c8f-4652-44e6-ba05-da5694e61be5 35 fields · synced Jun 8, 2026