Identity
- Trade Name
- The Tether™ FDA UDI
- Generic Name
- Spinal dynamic-stabilization system FDA UDI
- Device Name
- VERTEBRAL BODY TETHERING CLOSURE LOCK FDA UDI
- Model / Reference
- 211H0001 FDA UDI
- Description
- VERTEBRAL BODY TETHERING CLOSURE LOCK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887868531828 FDA UDI
- FDA Product Code
- QHP FDA UDI
- GMDN Term
- Spinal dynamic-stabilization system 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Spinal dynamic-stabilization system
The Tether™ by Zimmer Biomet — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Dynesys® — Zimmer, 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 N | Pending data |
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Manufacturer
- Manufacturer
- Zimmer Biomet
Sources (1)
- FDA UDI a72ffeb7-5c2f-4dcb-87d6-db50d7cb0d99 33 fields · synced May 31, 2026