MectaLIF Anterior Stand Alone Extension
K-Number: K183426 · 2019-03-15
ApplicantMedacta International S.A.
Decision Date2019-03-15
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MectaLIF Anterior Stand Alone Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2019-03-15 under approval number K183426. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MectaLIF Anterior Stand Alone Extension?
MectaLIF Anterior Stand Alone Extension is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by Medacta International S.A.. The 510(k) number is K183426.
When was MectaLIF Anterior Stand Alone Extension approved by the FDA?
MectaLIF Anterior Stand Alone Extension received FDA 510(k) clearance on 2019-03-15, under approval number K183426.
What company makes MectaLIF Anterior Stand Alone Extension?
MectaLIF Anterior Stand Alone Extension is manufactured by Medacta International S.A..
What is the FDA product code for MectaLIF Anterior Stand Alone Extension?
The FDA product code for MectaLIF Anterior Stand Alone Extension is OVD.
Related Clinical Trials
NCT07585305
Comparative Effects of Blood Flow Restriction Resistance Training Versus Blood Flow Restriction Cycling on Pain, Quadriceps Strength, and Functional Outcomes in Athletes With Patellofemoral Pain
NOT_YET_RECRUITING
NCT05762055
Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
ENROLLING_BY_INVITATION
NCT06938607
Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement
NOT_YET_RECRUITING
NCT06893653
Focal Muscle Vibration and tDCS on Motor Recovery in Stroke
COMPLETED
NCT07286474
Effects of Laser Therapy and Vitamin D Pills on Braces Tooth Movement: A Random Controlled Study
ACTIVE_NOT_RECRUITING
NCT07553013
Functional Proprioceptive Stimulation and Continuous Passive Motion Rehabilitation Interventions After Anterior Cruciate Ligament Reconstruction
COMPLETED
Other Devices by Medacta International S.A.
Related Devices (Code: OVD)
K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.
K162351SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation
K161993Leva® Anterior Interbody SystemSpine Wave, Inc.
K161379ELSA SpacersGlobus Medical, Inc.
K161173Avenue® T TLIF CageLdr Spine USA, Inc.
K161129PILLAR SA PTCOrthofix, 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.