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FDA 510(k)

Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V

K-Number: K220348 · 2022-07-14

ApplicantRemex Medical Corporation
Decision Date2022-07-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V is a medical device manufactured by Remex Medical Corporation. It received FDA 510(k) clearance on 2022-07-14 under approval number K220348. 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 Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V?

Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V is a medical device that received FDA 510(k) clearance on 2022-07-14. It is manufactured by Remex Medical Corporation. The 510(k) number is K220348.

When was Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V approved by the FDA?

Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V received FDA 510(k) clearance on 2022-07-14, under approval number K220348.

What company makes Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V?

Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V is manufactured by Remex Medical Corporation.

What is the FDA product code for Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V?

The FDA product code for Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V is OLO.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40902105 Design of Automatic Tool Replacement Mechanism for Laparoscopic Surgical Robot Arm for Solo Surgery. The international journal of medical robotics + computer assisted surgery : MRCAS (2025)

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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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