CREED Cannulated Screws
K-Number: K200291 · 2020-12-16
ApplicantGlw Medical, Inc.
Decision Date2020-12-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CREED Cannulated Screws is a medical device manufactured by Glw Medical, Inc.. It received FDA 510(k) clearance on 2020-12-16 under approval number K200291. 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 CREED Cannulated Screws?
CREED Cannulated Screws is a medical device that received FDA 510(k) clearance on 2020-12-16. It is manufactured by Glw Medical, Inc.. The 510(k) number is K200291.
When was CREED Cannulated Screws approved by the FDA?
CREED Cannulated Screws received FDA 510(k) clearance on 2020-12-16, under approval number K200291.
What company makes CREED Cannulated Screws?
CREED Cannulated Screws is manufactured by Glw Medical, Inc..
What is the FDA product code for CREED Cannulated Screws?
The FDA product code for CREED Cannulated Screws is HWC. This falls under the Cardiovascular category.
Other Devices by Glw Medical, 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.