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FDA 510(k)

Monterey AL Interbody System

K-Number: K201585 · 2020-08-10

ApplicantStryker Corporation
Decision Date2020-08-10
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Monterey AL Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2020-08-10 under 510(k) number K201585. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monterey AL Interbody System?

Monterey AL Interbody System is a medical device that received FDA 510(k) clearance on 2020-08-10. The listed applicant is Stryker Corporation. The 510(k) number is K201585.

When did Monterey AL Interbody System receive FDA 510(k) clearance?

Monterey AL Interbody System received FDA 510(k) clearance on 2020-08-10, under 510(k) number K201585.

Who is the listed applicant for Monterey AL Interbody System?

The FDA 510(k) record lists Stryker Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monterey AL Interbody System?

The FDA product code for Monterey AL Interbody System is OVD.

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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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