Headless Compression Screw System
K-Number: K200259 · 2020-05-04
ApplicantOsteocentric Extremities, LLC
Decision Date2020-05-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Headless Compression Screw System is a medical device manufactured by Osteocentric Extremities, LLC. It received FDA 510(k) clearance on 2020-05-04 under approval number K200259. 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 Headless Compression Screw System?
Headless Compression Screw System is a medical device that received FDA 510(k) clearance on 2020-05-04. It is manufactured by Osteocentric Extremities, LLC. The 510(k) number is K200259.
When was Headless Compression Screw System approved by the FDA?
Headless Compression Screw System received FDA 510(k) clearance on 2020-05-04, under approval number K200259.
What company makes Headless Compression Screw System?
Headless Compression Screw System is manufactured by Osteocentric Extremities, LLC.
What is the FDA product code for Headless Compression Screw System?
The FDA product code for Headless 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
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.