Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CONFIDENCE Spinal Cement System

K-Number: K201831 · 2020-08-31

ApplicantDepuy Spine, Inc.
Decision Date2020-08-31
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONFIDENCE Spinal Cement System is a medical device manufactured by Depuy Spine, Inc.. It received FDA 510(k) clearance on 2020-08-31 under approval number K201831. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONFIDENCE Spinal Cement System?

CONFIDENCE Spinal Cement System is a medical device that received FDA 510(k) clearance on 2020-08-31. It is manufactured by Depuy Spine, Inc.. The 510(k) number is K201831.

When was CONFIDENCE Spinal Cement System approved by the FDA?

CONFIDENCE Spinal Cement System received FDA 510(k) clearance on 2020-08-31, under approval number K201831.

What company makes CONFIDENCE Spinal Cement System?

CONFIDENCE Spinal Cement System is manufactured by Depuy Spine, Inc..

What is the FDA product code for CONFIDENCE Spinal Cement System?

The FDA product code for CONFIDENCE Spinal Cement System is NDN.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED NCT07607899 Virtual Reality for Pain and Well-Being in Older Adults NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Related Devices (Code: NDN)

K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)Pan Medical , Ltd. K160983Kyphon HV-R Bone CementMedtronic, Inc. K153296MEDINAUT Kyphoplasty SystemImedicom Co., Ltd. K152557Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. K161114HIGH V+Teknimed Sas

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.

↑