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FDA 510(k)

ASTRA Spine System

K-Number: K223273 · 2022-12-22

ApplicantSpinecraft, LLC
Decision Date2022-12-22
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASTRA Spine System is a medical device manufactured by Spinecraft, LLC. It received FDA 510(k) clearance on 2022-12-22 under approval number K223273. 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 ASTRA Spine System?

ASTRA Spine System is a medical device that received FDA 510(k) clearance on 2022-12-22. It is manufactured by Spinecraft, LLC. The 510(k) number is K223273.

When was ASTRA Spine System approved by the FDA?

ASTRA Spine System received FDA 510(k) clearance on 2022-12-22, under approval number K223273.

What company makes ASTRA Spine System?

ASTRA Spine System is manufactured by Spinecraft, LLC.

What is the FDA product code for ASTRA Spine System?

The FDA product code for ASTRA Spine System is NKB.

Related Clinical Trials

NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07574632 A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis. NOT_YET_RECRUITING NCT07574229 Support System Design for Adolescent Scoliosis Orthosis Wear RECRUITING

Other Devices by Spinecraft, LLC

K181350ASTRA-OCT Spine System K211935ORIO-Ti Intervertebral Body Fusion Cage System K211323ASTRA Spine System K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments 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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