Identity
- Trade Name
- The Tether™ FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- 6.0MM DIA X 50MM VBT ASSY FDA UDI
- Model / Reference
- 211H6050 FDA UDI
- Description
- 6.0MM DIA X 50MM VBT ASSY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00880304865013 FDA UDI
- FDA Product Code
- QHP FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General internal orthopaedic fixation system implantation kit
The Tether™ by Zimmer Biomet — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HONOUR™ Spacer System — NEXXT SPINE LLC · 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 N | Pending data |
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Manufacturer
- Manufacturer
- Zimmer Biomet
Sources (1)
- FDA UDI 593607cf-1d8c-475f-a1bf-e45a79ff3748 33 fields · synced Jun 8, 2026