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FDA 510(k)

AVS TL PEEK SPACERS

K-Number: K083661 · 2009-02-27

ApplicantStryker Corp.
Decision Date2009-02-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AVS TL PEEK SPACERS is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2009-02-27 under 510(k) number K083661. 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 TL PEEK SPACERS?

AVS TL PEEK SPACERS is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is Stryker Corp.. The 510(k) number is K083661.

When did AVS TL PEEK SPACERS receive FDA 510(k) clearance?

AVS TL PEEK SPACERS received FDA 510(k) clearance on 2009-02-27, under 510(k) number K083661.

Who is the listed applicant for AVS TL PEEK SPACERS?

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 TL PEEK SPACERS?

The FDA product code for AVS TL PEEK SPACERS is MAX.

Related Clinical Trials

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.

Other records listing Stryker Corp. as applicant

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.

View all 119 devices →

Related Devices (Code: MAX)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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