SMR TT Augmented Glenoid System
K-Number: K191746 · 2019-11-22
ApplicantLima Corporate S.P.A.
Decision Date2019-11-22
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SMR TT Augmented Glenoid System is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2019-11-22 under approval number K191746. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SMR TT Augmented Glenoid System?
SMR TT Augmented Glenoid System is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K191746.
When was SMR TT Augmented Glenoid System approved by the FDA?
SMR TT Augmented Glenoid System received FDA 510(k) clearance on 2019-11-22, under approval number K191746.
What company makes SMR TT Augmented Glenoid System?
SMR TT Augmented Glenoid System is manufactured by Lima Corporate S.P.A..
What is the FDA product code for SMR TT Augmented Glenoid System?
The FDA product code for SMR TT Augmented Glenoid System is PHX.
Related Clinical Trials
NCT07173309
Evaluation of Eye Gaze Sharing in the Operating Room
RECRUITING
NCT07174479
Eye Gaze Guidance Evaluation in Phantoms
COMPLETED
NCT07596550
Comparative Study of Augmented Reality and Virtual Reality in Music Therapy Interventions for Individuals With Cerebral Palsy
NOT_YET_RECRUITING
NCT05513027
Augmented Whole-body Scanning Via Magnifying PET/CT (AWSM-PET/CT) Techniques Abilities to Improve Upon the Diagnostic Accuracy of the Standard-of-care (SOC) PET/CT for Malignant Lesion Detection
TERMINATED
NCT06649357
Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate
RECRUITING
NCT07161024
AR Projections for Eye-gaze Evaluation in Phantoms
COMPLETED
Related PubMed Literature
Other Devices by Lima Corporate S.P.A.
Related Devices (Code: PHX)
K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.
K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation
K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp
K152966Aequalis Fx2Tornier S.A.S.
K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.
K170414Arthrex Univers Revers Apex Humeral StemsArthrex, 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.