Monster Screw System
K-Number: K203011 · 2020-11-13
ApplicantParagon 28, Inc.
Decision Date2020-11-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Monster Screw System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2020-11-13 under approval number K203011. 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 Monster Screw System?
Monster Screw System is a medical device that received FDA 510(k) clearance on 2020-11-13. It is manufactured by Paragon 28, Inc.. The 510(k) number is K203011.
When was Monster Screw System approved by the FDA?
Monster Screw System received FDA 510(k) clearance on 2020-11-13, under approval number K203011.
What company makes Monster Screw System?
Monster Screw System is manufactured by Paragon 28, Inc..
What is the FDA product code for Monster Screw System?
The FDA product code for Monster 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 Paragon 28, Inc.
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.