Tranquil-C™

FDA UDI

Class I (US FDA UDI)

by Nexus Spine, L.l.c.

Identity

Trade Name: Tranquil-C™ FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: Cervical Trial +DS 8x18x14 Lordotic FDA UDI
Model / Reference: 822463 FDA UDI
Description: Cervical Trial +DS 8x18x14 Lordotic FDA UDI

Identifiers

Primary DI / UDI-DI: B6788224630 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 18 Millimeter FDA UDI
Length — 14 Millimeter FDA UDI
Height — 8 Millimeter FDA UDI

Category: Surgical implant template, reusable

Tranquil-C™ by Nexus Spine, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MATISSE Anterior Cervical Interbody Fusion Cage System — CTL Medical Corporation · Class I

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: Nexus Spine, L.l.c.

Sources (1)

FDA UDI 746165b7-b2da-455d-849a-24b06f3b87bb 34 fields · synced Jun 1, 2026