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FDA 510(k)

ENNOVATE Spinal System

K-Number: K210963 · 2021-07-19

ApplicantAesculap Implant Systems, LLC
Decision Date2021-07-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENNOVATE Spinal System is a medical device manufactured by Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2021-07-19 under approval number K210963. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENNOVATE Spinal System?

ENNOVATE Spinal System is a medical device that received FDA 510(k) clearance on 2021-07-19. It is manufactured by Aesculap Implant Systems, LLC. The 510(k) number is K210963.

When was ENNOVATE Spinal System approved by the FDA?

ENNOVATE Spinal System received FDA 510(k) clearance on 2021-07-19, under approval number K210963.

What company makes ENNOVATE Spinal System?

ENNOVATE Spinal System is manufactured by Aesculap Implant Systems, LLC.

What is the FDA product code for ENNOVATE Spinal System?

The FDA product code for ENNOVATE Spinal System is NKB.

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 NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED

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)

Other Devices by Aesculap Implant Systems, LLC

K162134ENNOVATE Spinal System K153700Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments K153396Aesculap OrthoPilot Next Generation K180433ENNOVATE® K213871Ennovate Cervical Spinal and Occiput System

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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.

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