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FDA 510(k)

Ventana™ C Spinal System

K-Number: K222833 · 2023-05-19

ApplicantSpinal Elements, Inc.
Decision Date2023-05-19
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ventana™ C Spinal System 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 2023-05-19 under 510(k) number K222833. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ventana™ C Spinal System?

Ventana™ C Spinal System is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K222833.

When did Ventana™ C Spinal System receive FDA 510(k) clearance?

Ventana™ C Spinal System received FDA 510(k) clearance on 2023-05-19, under 510(k) number K222833.

Who is the listed applicant for Ventana™ C Spinal System?

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 Ventana™ C Spinal System?

The FDA product code for Ventana™ C Spinal System is ODP.

Other records listing Spinal Elements, Inc. as applicant

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Related Devices (Code: ODP)

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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