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FDA 510(k)

AVS PL PEEK SPACERS, MODELS 48351 AND 48353

K-Number: K080758 · 2008-03-27

ApplicantStryker Corp.
Decision Date2008-03-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AVS PL PEEK SPACERS, MODELS 48351 AND 48353 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2008-03-27 under 510(k) number K080758. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVS PL PEEK SPACERS, MODELS 48351 AND 48353?

AVS PL PEEK SPACERS, MODELS 48351 AND 48353 is a medical device that received FDA 510(k) clearance on 2008-03-27. The listed applicant is Stryker Corp.. The 510(k) number is K080758.

When did AVS PL PEEK SPACERS, MODELS 48351 AND 48353 receive FDA 510(k) clearance?

AVS PL PEEK SPACERS, MODELS 48351 AND 48353 received FDA 510(k) clearance on 2008-03-27, under 510(k) number K080758.

Who is the listed applicant for AVS PL PEEK SPACERS, MODELS 48351 AND 48353?

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

What is the FDA product code for AVS PL PEEK SPACERS, MODELS 48351 AND 48353?

The FDA product code for AVS PL PEEK SPACERS, MODELS 48351 AND 48353 is MAX.

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Related Devices (Code: MAX)

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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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