OrthoPediatrics Cannulated Screw System
K-Number: K190324 · 2019-07-05
ApplicantOrthoPediatrics Corp.
Decision Date2019-07-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OrthoPediatrics Cannulated Screw System is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2019-07-05 under approval number K190324. 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 OrthoPediatrics Cannulated Screw System?
OrthoPediatrics Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2019-07-05. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K190324.
When was OrthoPediatrics Cannulated Screw System approved by the FDA?
OrthoPediatrics Cannulated Screw System received FDA 510(k) clearance on 2019-07-05, under approval number K190324.
What company makes OrthoPediatrics Cannulated Screw System?
OrthoPediatrics Cannulated Screw System is manufactured by OrthoPediatrics Corp..
What is the FDA product code for OrthoPediatrics Cannulated Screw System?
The FDA product code for OrthoPediatrics Cannulated 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
NCT05762055
Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
ENROLLING_BY_INVITATION
NCT05565131
Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery
COMPLETED
NCT06720948
The ION Facet Screw System Ambispective Evaluation
ENROLLING_BY_INVITATION
NCT06960018
Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
RECRUITING
Other Devices by OrthoPediatrics Corp.
K162307OrthoPediatrics Locking Proximal Femur System Cortical Screws
K161267Response BandLoc Spinal Fixation
K160466Response 5.5 Spine System
K171173OrthoPediatrics Titanium PediPlates® System
K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
K190321Pediatric Nailing PlatformFemur
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.