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FDA 510(k)

AXSOS LOCKING PLATE SYSTEM

K-Number: K112926 · 2011-12-19

ApplicantStryker Corp.
Decision Date2011-12-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AXSOS LOCKING PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2011-12-19 under 510(k) number K112926. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXSOS LOCKING PLATE SYSTEM?

AXSOS LOCKING PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-19. The listed applicant is Stryker Corp.. The 510(k) number is K112926.

When did AXSOS LOCKING PLATE SYSTEM receive FDA 510(k) clearance?

AXSOS LOCKING PLATE SYSTEM received FDA 510(k) clearance on 2011-12-19, under 510(k) number K112926.

Who is the listed applicant for AXSOS LOCKING PLATE SYSTEM?

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 AXSOS LOCKING PLATE SYSTEM?

The FDA product code for AXSOS LOCKING PLATE SYSTEM is HRS.

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Other records listing Stryker Corp. as applicant

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Related Devices (Code: HRS)

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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