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FDA 510(k)

Spinal Elements Navigated Instruments

K-Number: K190881 · 2019-12-19

ApplicantSpinal Elements, Inc.
Decision Date2019-12-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spinal Elements Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K190881. 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 Spinal Elements Navigated Instruments?

Spinal Elements Navigated Instruments is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K190881.

When did Spinal Elements Navigated Instruments receive FDA 510(k) clearance?

Spinal Elements Navigated Instruments received FDA 510(k) clearance on 2019-12-19, under 510(k) number K190881.

Who is the listed applicant for Spinal Elements Navigated Instruments?

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

What is the FDA product code for Spinal Elements Navigated Instruments?

The FDA product code for Spinal Elements Navigated Instruments is OLO.

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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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