FDA 510(k)

CarboClear Lumbar Cage System

K-Number: K193378 · 2020-03-02

Decision Date2020-03-02

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CarboClear Lumbar Cage System is a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2020-03-02 under approval number K193378. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CarboClear Lumbar Cage System?

CarboClear Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2020-03-02. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K193378.

When was CarboClear Lumbar Cage System approved by the FDA?

CarboClear Lumbar Cage System received FDA 510(k) clearance on 2020-03-02, under approval number K193378.

What company makes CarboClear Lumbar Cage System?

CarboClear Lumbar Cage System is manufactured by CarboFix Orthopedics , Ltd..

What is the FDA product code for CarboClear Lumbar Cage System?

The FDA product code for CarboClear Lumbar Cage System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING NCT07494812 Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials NOT_YET_RECRUITING NCT07214844 A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain RECRUITING

Other Devices by CarboFix Orthopedics , Ltd.

K160002Piccolo Composite(R) Distal Volar Radius Plate System K153536Piccolo Composite® Nailing System K173652Piccolo Composite Nailing System K170401Piccolo Composite® Plate System K182015Piccolo Composite® Plate System K182377CarboClear® Pedicle Screw System

View all 25 devices →

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

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.