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)

Ennovate Cervical Spinal and Occiput System

K-Number: K213871 · 2022-07-01

ApplicantAesculap Implant Systems, LLC
Decision Date2022-07-01
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ennovate Cervical Spinal and Occiput System is a medical device manufactured by Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2022-07-01 under approval number K213871. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ennovate Cervical Spinal and Occiput System?

Ennovate Cervical Spinal and Occiput System is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Aesculap Implant Systems, LLC. The 510(k) number is K213871.

When was Ennovate Cervical Spinal and Occiput System approved by the FDA?

Ennovate Cervical Spinal and Occiput System received FDA 510(k) clearance on 2022-07-01, under approval number K213871.

What company makes Ennovate Cervical Spinal and Occiput System?

Ennovate Cervical Spinal and Occiput System is manufactured by Aesculap Implant Systems, LLC.

What is the FDA product code for Ennovate Cervical Spinal and Occiput System?

The FDA product code for Ennovate Cervical Spinal and Occiput System is NKG.

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 NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT07607665 Spinal Cord Associative Plasticity in Cerebral Palsy RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) 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)

Other Devices by Aesculap Implant Systems, LLC

K162134ENNOVATE Spinal System K153700Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments K153396Aesculap OrthoPilot Next Generation K180433ENNOVATE® K210963ENNOVATE Spinal System

Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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.

↑