A-CIFT SoloFuse— 510(k) K172484

Clearance details

Applicant

Spinefrontier, Inc.

Product code

Code OVE

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2017-08-17

Decision date

2018-05-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Malden, MA, US

• K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
• K261451 — ZSAlign Cervical Interbody System2026-07-31
• K262094 — E3D-C Interbody System2026-07-22
• K261279 — DeltaNEC Interbody System2026-06-22
• K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

• K193106 — SpineFrontier Lumbar Interbody Fusion Device System2020-06-19
• K151198 — A-CIFT SoloFuse2015-07-17
• K142504 — SpineFrontier Lumbar Interbody Fusion Device System2015-05-13
• K150017 — SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System2015-04-24
• K143377 — PedFuse Pedicle Screw System2015-02-12

Injury

293

Malfunction

710

Total

1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1973-2019 — A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)Class II·Terminated·SpineFrontier, Inc.·20190613

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172484.