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FDA 510(k)

Stryker Resorbable Fixation System

K-Number: K213777 · 2022-02-04

ApplicantStryker Leibinger Micro Implants
Decision Date2022-02-04
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Stryker Resorbable Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger Micro Implants. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K213777. 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 Resorbable Fixation System?

Stryker Resorbable Fixation System is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Stryker Leibinger Micro Implants. The 510(k) number is K213777.

When did Stryker Resorbable Fixation System receive FDA 510(k) clearance?

Stryker Resorbable Fixation System received FDA 510(k) clearance on 2022-02-04, under 510(k) number K213777.

Who is the listed applicant for Stryker Resorbable Fixation System?

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

What is the FDA product code for Stryker Resorbable Fixation System?

The FDA product code for Stryker Resorbable Fixation System is JEY.

Related Devices (Code: JEY)

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.

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.K240651MRI UniversalStryker Leibinger GmbH & Co KG

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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