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FDA 510(k)

ASTRA-OCT Spine System

K-Number: K181350 · 2018-07-06

ApplicantSpinecraft, LLC
Decision Date2018-07-06
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASTRA-OCT Spine System is a medical device manufactured by Spinecraft, LLC. It received FDA 510(k) clearance on 2018-07-06 under approval number K181350. 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 ASTRA-OCT Spine System?

ASTRA-OCT Spine System is a medical device that received FDA 510(k) clearance on 2018-07-06. It is manufactured by Spinecraft, LLC. The 510(k) number is K181350.

When was ASTRA-OCT Spine System approved by the FDA?

ASTRA-OCT Spine System received FDA 510(k) clearance on 2018-07-06, under approval number K181350.

What company makes ASTRA-OCT Spine System?

ASTRA-OCT Spine System is manufactured by Spinecraft, LLC.

What is the FDA product code for ASTRA-OCT Spine System?

The FDA product code for ASTRA-OCT Spine System is NKG.

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

Related PubMed Literature

PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by Spinecraft, LLC

K211935ORIO-Ti Intervertebral Body Fusion Cage System K211323ASTRA Spine System K223273ASTRA Spine System K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments 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.

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