Velofix Interbody Fusion System
K-Number: K190067 · 2019-02-04
ApplicantU&I Corporation
Decision Date2019-02-04
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Velofix Interbody Fusion System is a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2019-02-04 under approval number K190067. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Velofix Interbody Fusion System?
Velofix Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-02-04. It is manufactured by U&I Corporation. The 510(k) number is K190067.
When was Velofix Interbody Fusion System approved by the FDA?
Velofix Interbody Fusion System received FDA 510(k) clearance on 2019-02-04, under approval number K190067.
What company makes Velofix Interbody Fusion System?
Velofix Interbody Fusion System is manufactured by U&I Corporation.
What is the FDA product code for Velofix Interbody Fusion System?
The FDA product code for Velofix Interbody Fusion System is ODP.
Related Clinical Trials
NCT07222787
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
RECRUITING
NCT06462729
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
RECRUITING
NCT05438719
MOTUS Total Joint Replacement Investigational Device Exemption Study
ACTIVE_NOT_RECRUITING
NCT04823858
3Spine Lumbar Fusion Real World Evidence Study
ACTIVE_NOT_RECRUITING
NCT05762055
Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
ENROLLING_BY_INVITATION
NCT07017634
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease
RECRUITING
Related PubMed Literature
Other Devices by U&I Corporation
Related Devices (Code: ODP)
K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.
K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education
K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company
K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.
K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd.
K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC
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.