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: Steerable IBD 17x11x37, 6deg FDA UDI
Model / Reference: 522088 FDA UDI
Description: Steerable IBD 17x11x37, 6deg FDA UDI

Identifiers

Primary DI / UDI-DI: B6785220880 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 11 Millimeter FDA UDI
Length — 37 Millimeter FDA UDI
Height — 17 Millimeter FDA UDI

Category: Metallic spinal interbody fusion cage

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

Similar devices

Also classified as Metallic spinal interbody fusion cage.

KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° — MET 1 TECHNOLOGIES, LLC · Class II
Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
CoRoent — Nuvasive, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
MectaLIF 3D — Medacta International · Class II
PILLAR TL — Orthofix US LLC · Class II
Solar™ Interbody Fusion System — Degen Medical · Class II
Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II

Cleared under the same submission

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Nexus Spine, L.l.c.

Sources (1)

FDA UDI 32c7d8b8-e501-4362-be77-5498a54b5fce 35 fields · synced May 31, 2026