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FDA 510(k)

Aspida® Anterior Lumbar Plating System

K-Number: K182808 · 2018-11-09

ApplicantAlphatec Spine, Inc.
Decision Date2018-11-09
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aspida® Anterior Lumbar Plating 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 2018-11-09 under 510(k) number K182808. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aspida® Anterior Lumbar Plating System?

Aspida® Anterior Lumbar Plating System is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K182808.

When did Aspida® Anterior Lumbar Plating System receive FDA 510(k) clearance?

Aspida® Anterior Lumbar Plating System received FDA 510(k) clearance on 2018-11-09, under 510(k) number K182808.

Who is the listed applicant for Aspida® Anterior Lumbar Plating 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 Aspida® Anterior Lumbar Plating System?

The FDA product code for Aspida® Anterior Lumbar Plating System is KWQ.

Other records listing Alphatec Spine, Inc. as applicant

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Related Devices (Code: KWQ)

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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