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FDA 510(k)

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II

K-Number: K251315 · 2025-05-29

ApplicantRemex Medical Corp.
Decision Date2025-05-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is the device name listed in this FDA 510(k) record. The listed applicant is Remex Medical Corp.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K251315. 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 and Remex Spine Surgery Navigation System II?

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Remex Medical Corp.. The 510(k) number is K251315.

When did Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II receive FDA 510(k) clearance?

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II received FDA 510(k) clearance on 2025-05-29, under 510(k) number K251315.

Who is the listed applicant for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II?

The FDA 510(k) record lists Remex Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II?

The FDA product code for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is OLO.

Other records listing Remex Medical Corp. 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.

K243560Remex Spine Surgery Navigation InstrumentK241625Anatase Navi Disposable InstrumentK233513Remex Spine Surgery Navigation System IIK230783Anatase Spine Surgery Navigation SystemK220348Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V

Related Devices (Code: OLO)

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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