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)

Dolphix® External Fixation System MR Conditional

K-Number: K163323 · 2017-03-20

ApplicantCitieffe S.R.L.
Decision Date2017-03-20
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dolphix® External Fixation System MR Conditional is a medical device manufactured by Citieffe S.R.L.. It received FDA 510(k) clearance on 2017-03-20 under approval number K163323. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dolphix® External Fixation System MR Conditional?

Dolphix® External Fixation System MR Conditional is a medical device that received FDA 510(k) clearance on 2017-03-20. It is manufactured by Citieffe S.R.L.. The 510(k) number is K163323.

When was Dolphix® External Fixation System MR Conditional approved by the FDA?

Dolphix® External Fixation System MR Conditional received FDA 510(k) clearance on 2017-03-20, under approval number K163323.

What company makes Dolphix® External Fixation System MR Conditional?

Dolphix® External Fixation System MR Conditional is manufactured by Citieffe S.R.L..

What is the FDA product code for Dolphix® External Fixation System MR Conditional?

The FDA product code for Dolphix® External Fixation System MR Conditional is KTT.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING

Other Devices by Citieffe S.R.L.

K180150PL8 Wrist Reconstruction Plate K183666EBA One Nailing System K181540Estremo Citieffe Nailing System K250197Estremo Fibular Nail

Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, 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.

↑