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FDA 510(k)

AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX

K-Number: K093864 · 2010-03-11

ApplicantStryker Corp.
Decision Date2010-03-11
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2010-03-11 under 510(k) number K093864. 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 ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX?

AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX is a medical device that received FDA 510(k) clearance on 2010-03-11. The listed applicant is Stryker Corp.. The 510(k) number is K093864.

When did AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX receive FDA 510(k) clearance?

AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX received FDA 510(k) clearance on 2010-03-11, under 510(k) number K093864.

Who is the listed applicant for AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX?

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 ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX?

The FDA product code for AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX is 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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