Stabilis

FDA UDI

Class II (US FDA UDI)

by Acuity Surgical Devices, Llc

Identity

Trade Name: Stabilis FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: Stabilis Cervical 18mm x 15mm x 12mm x 15 deg Trial FDA UDI
Model / Reference: 35-18151215 FDA UDI
Description: Stabilis Cervical 18mm x 15mm x 12mm x 15 deg Trial FDA UDI

Identifiers

Primary DI / UDI-DI: 00810161113965 FDA UDI
510(k) Number: K230639 FDA UDI
FDA Product Code: ODP 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

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 18 Millimeter FDA UDI
Width — 15 Millimeter FDA UDI
Height — 12 Millimeter FDA UDI
Angle — 15 degree FDA UDI

Category: Metallic spinal interbody fusion cage

Stabilis by Acuity Surgical Devices, Llc — 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

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Manufacturer

Manufacturer: Acuity Surgical Devices, Llc

Sources (1)

FDA UDI 44405a4e-c34c-487f-845d-30fc414b38f4 36 fields · synced Jun 8, 2026