The Tether™

FDA UDI

Class I (US FDA UDI)

by Zimmer Biomet

Identity

Trade Name: The Tether™ FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: CORD ALIGNMENT ROD FDA UDI
Model / Reference: 230H4004 FDA UDI
Description: CORD ALIGNMENT ROD FDA UDI

Identifiers

Primary DI / UDI-DI: 00887868262890 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Spinal implant trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Spinal implant trial

The Tether™ by Zimmer Biomet — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Zimmer Biomet

Sources (1)

FDA UDI a38562f7-46a4-45bc-a2e6-cf710128a1f7 33 fields · synced Jun 6, 2026