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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 the device name listed in this FDA 510(k) record. The listed applicant is Spinecraft, LLC. It received FDA 510(k) clearance on 2018-07-06 under 510(k) 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. The listed applicant is Spinecraft, LLC. The 510(k) number is K181350.

When did ASTRA-OCT Spine System receive FDA 510(k) clearance?

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

Who is the listed applicant for ASTRA-OCT Spine System?

The FDA 510(k) record lists Spinecraft, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Spinecraft, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253260ORIO-3D Cage SystemK260015ANTERIS Thoracolumbar Plate SystemK223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemK223273ASTRA Spine SystemK211935ORIO-Ti Intervertebral Body Fusion Cage SystemK211323ASTRA Spine System

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., 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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