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FDA 510(k)

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System

K-Number: K223301 · 2023-07-20

ApplicantSpinecraft, LLC
Decision Date2023-07-20
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System is a medical device manufactured by Spinecraft, LLC. It received FDA 510(k) clearance on 2023-07-20 under approval number K223301. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System?

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System is a medical device that received FDA 510(k) clearance on 2023-07-20. It is manufactured by Spinecraft, LLC. The 510(k) number is K223301.

When was ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System approved by the FDA?

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System received FDA 510(k) clearance on 2023-07-20, under approval number K223301.

What company makes ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System?

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System is manufactured by Spinecraft, LLC.

What is the FDA product code for ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System?

The FDA product code for ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System is OLO.

Related Clinical Trials

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Related PubMed Literature

PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Spinecraft, LLC

K181350ASTRA-OCT Spine System K211935ORIO-Ti Intervertebral Body Fusion Cage System K211323ASTRA Spine System K223273ASTRA Spine System

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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