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FDA 510(k)

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System

K-Number: K231460 · 2023-07-16

ApplicantK&J Consulting Corp.
Decision Date2023-07-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System is a medical device manufactured by K&J Consulting Corp.. It received FDA 510(k) clearance on 2023-07-16 under approval number K231460. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System?

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2023-07-16. It is manufactured by K&J Consulting Corp.. The 510(k) number is K231460.

When was FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System approved by the FDA?

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System received FDA 510(k) clearance on 2023-07-16, under approval number K231460.

What company makes FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System?

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System is manufactured by K&J Consulting Corp..

What is the FDA product code for FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System?

The FDA product code for FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System is KWQ.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED

Other Devices by K&J Consulting Corp.

K233332Statera-C™ Spinal System K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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