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FDA 510(k)

Ascend VBR System, Ascend NanoTec VBR System

K-Number: K232173 · 2023-10-06

ApplicantAlphatec Spine, Inc.
Decision Date2023-10-06
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ascend VBR System, Ascend NanoTec VBR System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232173. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ascend VBR System, Ascend NanoTec VBR System?

Ascend VBR System, Ascend NanoTec VBR System is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K232173.

When did Ascend VBR System, Ascend NanoTec VBR System receive FDA 510(k) clearance?

Ascend VBR System, Ascend NanoTec VBR System received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232173.

Who is the listed applicant for Ascend VBR System, Ascend NanoTec VBR System?

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

What is the FDA product code for Ascend VBR System, Ascend NanoTec VBR System?

The FDA product code for Ascend VBR System, Ascend NanoTec VBR System is MQP.

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Related Devices (Code: MQP)

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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