Stable-L™

FDA UDI

Class II (US FDA UDI)

by Nexus Spine, L.l.c.

Identity

Trade Name: Stable-L™ FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: Stable-L Interbody 30x24x16, 12 Deg FDA UDI
Model / Reference: 525161S FDA UDI
Description: Stable-L Interbody 30x24x16, 12 Deg FDA UDI

Identifiers

Primary DI / UDI-DI: B678525161S0 FDA UDI
510(k) Number: K231486 FDA UDI
K232530 FDA UDI
K243934 FDA UDI
FDA Product Code: OVD FDA UDI
OVE 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

Category: Metallic spinal interbody fusion cage

Stable-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

K231486 also covers:

K232530 also covers:

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 b1b3f6fe-aaf1-4136-af25-96a4431da2b1 34 fields · synced Jun 1, 2026