Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Stryker SternalPlate System

K-Number: K183172 · 2019-03-05

ApplicantStryker
Decision Date2019-03-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stryker SternalPlate System is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2019-03-05 under approval number K183172. 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 Stryker SternalPlate System?

Stryker SternalPlate System is a medical device that received FDA 510(k) clearance on 2019-03-05. It is manufactured by Stryker. The 510(k) number is K183172.

When was Stryker SternalPlate System approved by the FDA?

Stryker SternalPlate System received FDA 510(k) clearance on 2019-03-05, under approval number K183172.

What company makes Stryker SternalPlate System?

Stryker SternalPlate System is manufactured by Stryker.

What is the FDA product code for Stryker SternalPlate System?

The FDA product code for Stryker SternalPlate System is HRS.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07245758 Facial iD Customized Mandible Reconstruction Plates COMPLETED NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07245810 Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up ACTIVE_NOT_RECRUITING NCT07221916 Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up COMPLETED

Other Devices by Stryker

K161821Stryker Universal Mesh K162310XBraid TT Suture Tape K162262Tritanium® PL Cage K160955Tritanium® PL Cage K153248PEEK Customized Cranial Implant K153508Stryker CMF MEDPOR Customized Implant

View all 64 devices →

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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.

↑