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FDA 510(k)

Solo Pace Fusion System (SOLOFUSE1)

K-Number: K252674 · 2026-01-09

ApplicantSolo Pace, Inc.
Decision Date2026-01-09
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Solo Pace Fusion System (SOLOFUSE1) is a medical device manufactured by Solo Pace, Inc.. It received FDA 510(k) clearance on 2026-01-09 under approval number K252674. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solo Pace Fusion System (SOLOFUSE1)?

Solo Pace Fusion System (SOLOFUSE1) is a medical device that received FDA 510(k) clearance on 2026-01-09. It is manufactured by Solo Pace, Inc.. The 510(k) number is K252674.

When was Solo Pace Fusion System (SOLOFUSE1) approved by the FDA?

Solo Pace Fusion System (SOLOFUSE1) received FDA 510(k) clearance on 2026-01-09, under approval number K252674.

What company makes Solo Pace Fusion System (SOLOFUSE1)?

Solo Pace Fusion System (SOLOFUSE1) is manufactured by Solo Pace, Inc..

What is the FDA product code for Solo Pace Fusion System (SOLOFUSE1)?

The FDA product code for Solo Pace Fusion System (SOLOFUSE1) is DQX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION

Other Devices by Solo Pace, Inc.

K241781Solo Pace Control

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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