Cannulated Screw Internal Fixation System
K-Number: K173286 · 2017-12-14
ApplicantLife Spine, Inc.
Decision Date2017-12-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Cannulated Screw Internal Fixation System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2017-12-14 under approval number K173286. 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 Cannulated Screw Internal Fixation System?
Cannulated Screw Internal Fixation System is a medical device that received FDA 510(k) clearance on 2017-12-14. It is manufactured by Life Spine, Inc.. The 510(k) number is K173286.
When was Cannulated Screw Internal Fixation System approved by the FDA?
Cannulated Screw Internal Fixation System received FDA 510(k) clearance on 2017-12-14, under approval number K173286.
What company makes Cannulated Screw Internal Fixation System?
Cannulated Screw Internal Fixation System is manufactured by Life Spine, Inc..
What is the FDA product code for Cannulated Screw Internal Fixation System?
The FDA product code for Cannulated Screw Internal Fixation 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
NCT07277946
AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
RECRUITING
NCT06958731
In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial
ENROLLING_BY_INVITATION
NCT05762055
Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
ENROLLING_BY_INVITATION
NCT05883202
Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants
SUSPENDED
NCT07574229
Support System Design for Adolescent Scoliosis Orthosis Wear
RECRUITING
Other Devices by Life Spine, 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.