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FDA 510(k)

ALTA Anterior Cervical Corpectomy System

K-Number: K190426 · 2019-10-24

ApplicantAstura Medical, LLC
Decision Date2019-10-24
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALTA Anterior Cervical Corpectomy System is a medical device manufactured by Astura Medical, LLC. It received FDA 510(k) clearance on 2019-10-24 under approval number K190426. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALTA Anterior Cervical Corpectomy System?

ALTA Anterior Cervical Corpectomy System is a medical device that received FDA 510(k) clearance on 2019-10-24. It is manufactured by Astura Medical, LLC. The 510(k) number is K190426.

When was ALTA Anterior Cervical Corpectomy System approved by the FDA?

ALTA Anterior Cervical Corpectomy System received FDA 510(k) clearance on 2019-10-24, under approval number K190426.

What company makes ALTA Anterior Cervical Corpectomy System?

ALTA Anterior Cervical Corpectomy System is manufactured by Astura Medical, LLC.

What is the FDA product code for ALTA Anterior Cervical Corpectomy System?

The FDA product code for ALTA Anterior Cervical Corpectomy System is PLR.

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Other Devices by Astura Medical, LLC

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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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