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Tranquil-L™

FDA UDI

Class II (US FDA UDI)

by Nexus Spine, L.l.c.

Identity

Trade Name
Tranquil-L™ FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
Large Forward Angle Curette FDA UDI
Model / Reference
823144 FDA UDI
Description
Large Forward Angle Curette FDA UDI

Identifiers

Primary DI / UDI-DI
B6788231440 FDA UDI
510(k) Number
K170297 FDA UDI
K181483 FDA UDI
K181702 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K170297 also covers:

K181483 also covers:

K181702 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nexus Spine, L.l.c.

Sources (1)

  • FDA UDI b63a69d4-6a05-43ff-8251-95539254f3a4 35 fields · synced Jun 1, 2026