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FDA 510(k)

STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM

K-Number: K122313 · 2012-10-31

ApplicantStryker
Decision Date2012-10-31
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2012-10-31 under 510(k) number K122313. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM?

STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-31. The listed applicant is Stryker. The 510(k) number is K122313.

When did STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM receive FDA 510(k) clearance?

STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM received FDA 510(k) clearance on 2012-10-31, under 510(k) number K122313.

Who is the listed applicant for STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM?

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

What is the FDA product code for STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM?

The FDA product code for STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM is JEY.

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Related Devices (Code: JEY)

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K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

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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