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FDA 510(k)

Invictus® Bone Cement, Invictus Spinal Fixation System

K-Number: K221926 · 2022-12-20

ApplicantAlphatec Spine, Inc.
Decision Date2022-12-20
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Invictus® Bone Cement, Invictus Spinal Fixation System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2022-12-20 under approval number K221926. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Invictus® Bone Cement, Invictus Spinal Fixation System?

Invictus® Bone Cement, Invictus Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-12-20. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K221926.

When was Invictus® Bone Cement, Invictus Spinal Fixation System approved by the FDA?

Invictus® Bone Cement, Invictus Spinal Fixation System received FDA 510(k) clearance on 2022-12-20, under approval number K221926.

What company makes Invictus® Bone Cement, Invictus Spinal Fixation System?

Invictus® Bone Cement, Invictus Spinal Fixation System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for Invictus® Bone Cement, Invictus Spinal Fixation System?

The FDA product code for Invictus® Bone Cement, Invictus Spinal Fixation System is PML.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes 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 NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE 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 Alphatec Spine, Inc.

K160646XYcor® Expandable Spinal Spacer System K161363Arsenal Spinal Fixation System K153603Alphatec Navigation Instruments K173522Solanas® Posterior Stabilization System K182746ATEC ALIF and LLIF Spacer System K182808Aspida® Anterior Lumbar Plating System

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Related Devices (Code: PML)

K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc. K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , Ltd.

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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