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FDA 510(k)

Navigated Pedicle Access Kit

K-Number: K191012 · 2019-08-07

ApplicantIzi Medical Products, LLC
Decision Date2019-08-07
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navigated Pedicle Access Kit is the device name listed in this FDA 510(k) record. The listed applicant is Izi Medical Products, LLC. It received FDA 510(k) clearance on 2019-08-07 under 510(k) number K191012. 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 Navigated Pedicle Access Kit?

Navigated Pedicle Access Kit is a medical device that received FDA 510(k) clearance on 2019-08-07. The listed applicant is Izi Medical Products, LLC. The 510(k) number is K191012.

When did Navigated Pedicle Access Kit receive FDA 510(k) clearance?

Navigated Pedicle Access Kit received FDA 510(k) clearance on 2019-08-07, under 510(k) number K191012.

Who is the listed applicant for Navigated Pedicle Access Kit?

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

What is the FDA product code for Navigated Pedicle Access Kit?

The FDA product code for Navigated Pedicle Access Kit is OLO.

Other records listing Izi Medical Products, 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.

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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.

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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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