Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ion-C

K-Number: K251714 · 2026-01-16

ApplicantSurGenTec, LLC
Decision Date2026-01-16
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

Ion-C is a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2026-01-16 under approval number K251714. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ion-C?

Ion-C is a medical device that received FDA 510(k) clearance on 2026-01-16. It is manufactured by SurGenTec, LLC. The 510(k) number is K251714.

When was Ion-C approved by the FDA?

Ion-C received FDA 510(k) clearance on 2026-01-16, under approval number K251714.

What company makes Ion-C?

Ion-C is manufactured by SurGenTec, LLC.

What is the FDA product code for Ion-C?

The FDA product code for Ion-C is MRW.

Other Devices by SurGenTec, LLC

K170675Graftgun Universal Graft Delivery System K180937Graftgun Universal Graft Delivery System K190163ALARA Neuro Access Kit K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft K211855Ion Facet Screw System K231716OsteoFlo® HydroPutty™

View all 23 devices →

Related Devices (Code: MRW)

K161798FacetBRIDGE® SystemLdr Spine USA, Inc. K152137FacetBRIDGE SystemLdr Spine USA K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. K180729FaSet Fixation SystemHuvexel Co. , Ltd. K173198Facet Screw Fixation SystemU&I Corporation K192744CORRIDOR Fixation SystemGlobus Medical, Inc.

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.

↑