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FDA 510(k)

Choice Spine Navigation System

K-Number: K182721 · 2019-01-08

ApplicantChoicespine, LP
Decision Date2019-01-08
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Choice Spine Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2019-01-08 under 510(k) number K182721. 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 Choice Spine Navigation System?

Choice Spine Navigation System is a medical device that received FDA 510(k) clearance on 2019-01-08. The listed applicant is Choicespine, LP. The 510(k) number is K182721.

When did Choice Spine Navigation System receive FDA 510(k) clearance?

Choice Spine Navigation System received FDA 510(k) clearance on 2019-01-08, under 510(k) number K182721.

Who is the listed applicant for Choice Spine Navigation System?

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

What is the FDA product code for Choice Spine Navigation System?

The FDA product code for Choice Spine Navigation System is OLO.

Other records listing Choicespine, LP as applicant

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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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