A-CIFT SoloFuse

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K172484

by Spinefrontier, Inc.

Identity

Trade Name: A-CIFT® SoloFuse® FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 9mm Height HA PEEK FDA UDI
Model / Reference: 01-32020-09-HA FDA UDI
Description: A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 9mm Height HA PEEK FDA UDI

Identifiers

Primary DI / UDI-DI: 00190361023692 FDA UDI
510(k) Number: K172484 FDA 510(k)FDA UDI
FDA Product Code: OVE FDA 510(k)FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 888.3080 FDA 510(k)
Regulation Number: 888.3080 FDA 510(k)FDA UDI
Advisory Committee: Orthopedic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
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

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 17 Millimeter FDA UDI
Height — 9 Millimeter FDA UDI
Length — 13 Millimeter FDA UDI

A-CIFT SoloFuse by Spinefrontier, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K172484	Class II	Active

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Manufacturer

Manufacturer: Spinefrontier, Inc.

Sources (2)

FDA 510(k) K172484 24 fields · synced Jun 19, 2026
FDA UDI 18e8198e-a652-4033-84f4-448574552344 36 fields · synced May 27, 2026