INNO SLA Submerged Hybrid Ti-Base System
K-Number: K231411 · 2023-12-20
ApplicantCowellmedi Co., Ltd.
Decision Date2023-12-20
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
INNO SLA Submerged Hybrid Ti-Base System is a medical device manufactured by Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2023-12-20 under approval number K231411. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the INNO SLA Submerged Hybrid Ti-Base System?
INNO SLA Submerged Hybrid Ti-Base System is a medical device that received FDA 510(k) clearance on 2023-12-20. It is manufactured by Cowellmedi Co., Ltd.. The 510(k) number is K231411.
When was INNO SLA Submerged Hybrid Ti-Base System approved by the FDA?
INNO SLA Submerged Hybrid Ti-Base System received FDA 510(k) clearance on 2023-12-20, under approval number K231411.
What company makes INNO SLA Submerged Hybrid Ti-Base System?
INNO SLA Submerged Hybrid Ti-Base System is manufactured by Cowellmedi Co., Ltd..
What is the FDA product code for INNO SLA Submerged Hybrid Ti-Base System?
The FDA product code for INNO SLA Submerged Hybrid Ti-Base System is NHA.
Related Clinical Trials
NCT07430293
Hybrid Closed-Loop Insulin Delivery After Pancreatectomy
RECRUITING
NCT04414280
The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs
ACTIVE_NOT_RECRUITING
NCT07034521
The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors
RECRUITING
NCT07569575
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
NOT_YET_RECRUITING
NCT07509060
HCL in Adults With T1DM, Markedly Elevated HbA1c, and Psychological Vulnerability
ACTIVE_NOT_RECRUITING
NCT07039617
A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET At Home)
RECRUITING
Other Devices by Cowellmedi Co., Ltd.
Related Devices (Code: NHA)
K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.
K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG
K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A.
K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.
K161435Temporary Snap AbutmentNobel Biocare AB
K160786RODO Abutment SystemRodo Medical, 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.