Healix Compression Screw System
K-Number: K182949 · 2018-12-04
ApplicantNvision Biomedical Technologies, LLC
Decision Date2018-12-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Healix Compression Screw System is a medical device manufactured by Nvision Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2018-12-04 under approval number K182949. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Healix Compression Screw System?
Healix Compression Screw System is a medical device that received FDA 510(k) clearance on 2018-12-04. It is manufactured by Nvision Biomedical Technologies, LLC. The 510(k) number is K182949.
When was Healix Compression Screw System approved by the FDA?
Healix Compression Screw System received FDA 510(k) clearance on 2018-12-04, under approval number K182949.
What company makes Healix Compression Screw System?
Healix Compression Screw System is manufactured by Nvision Biomedical Technologies, LLC.
What is the FDA product code for Healix Compression Screw System?
The FDA product code for Healix Compression Screw System is HWC. This falls under the Cardiovascular category.
Related Clinical Trials
NCT07222787
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
RECRUITING
NCT07609511
Magnet System Gastric Outlet Obstruction Study
NOT_YET_RECRUITING
NCT07603531
Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema
NOT_YET_RECRUITING
NCT07600489
A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers
NOT_YET_RECRUITING
NCT07317076
GT Metabolic Magnet System in Adults With Gastrointestinal Disorders
RECRUITING
NCT07431723
Creation of Compression Anastomosis Using the GT Metabolic Magnet System
RECRUITING
Other Devices by Nvision Biomedical Technologies, LLC
Related Devices (Code: HWC)
K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P.
K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific
K161778ToeTac 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek
K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC
K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.
K161449HammerTech Fixation SystemFusion Orthopedics, 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.