EM SA Implant System
K-Number: K191201 · 2019-11-15
ApplicantHiossen, Inc.
Decision Date2019-11-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EM SA Implant System is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2019-11-15 under approval number K191201. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EM SA Implant System?
EM SA Implant System is a medical device that received FDA 510(k) clearance on 2019-11-15. It is manufactured by Hiossen, Inc.. The 510(k) number is K191201.
When was EM SA Implant System approved by the FDA?
EM SA Implant System received FDA 510(k) clearance on 2019-11-15, under approval number K191201.
What company makes EM SA Implant System?
EM SA Implant System is manufactured by Hiossen, Inc..
What is the FDA product code for EM SA Implant System?
The FDA product code for EM SA Implant System is DZE.
Related Clinical Trials
NCT03280862
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
COMPLETED
NCT05391828
Persona MC vs PS RCT With ROSA
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
NCT05508360
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
RECRUITING
NCT05855135
Assessment of Combined CCM and ICD Device in HFrEF
ACTIVE_NOT_RECRUITING
NCT07287124
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
RECRUITING
Related PubMed Literature
PMID: 39892748
Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study.
Ophthalmology (2025)
PMID: 41966145
From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review".
International journal of health policy and management (2025)
PMID: 39726899
How to improve the mechanical safety of a novel spinal implant while saving costs and time.
JOR spine (2024)
Other Devices by Hiossen, Inc.
Related Devices (Code: DZE)
K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG
K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd.
K163043Zeramex P6 Dental Implant SystemDentalpoint AG
K161497Dental Implants and AbutmentsDitron Precision, Ltd.
K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.
K151970KJ Mini Implant SystemKj Meditech Co., Ltd.
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.