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FDA 510(k)

SHAPEMATCH CUTTING GUIDE

K-Number: K122053 · 2012-10-24

ApplicantStryker Corp.
Decision Date2012-10-24
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SHAPEMATCH CUTTING GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2012-10-24 under 510(k) number K122053. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHAPEMATCH CUTTING GUIDE?

SHAPEMATCH CUTTING GUIDE is a medical device that received FDA 510(k) clearance on 2012-10-24. The listed applicant is Stryker Corp.. The 510(k) number is K122053.

When did SHAPEMATCH CUTTING GUIDE receive FDA 510(k) clearance?

SHAPEMATCH CUTTING GUIDE received FDA 510(k) clearance on 2012-10-24, under 510(k) number K122053.

Who is the listed applicant for SHAPEMATCH CUTTING GUIDE?

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 SHAPEMATCH CUTTING GUIDE?

The FDA product code for SHAPEMATCH CUTTING GUIDE is MBH.

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Other records listing Stryker Corp. as applicant

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Related Devices (Code: MBH)

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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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