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FDA 510(k)

Medline ReNewal Reprocessed Stryker External Fixation Devices

K-Number: K163028 · 2016-12-28

ApplicantSurgical Instrument Service and Savings, Inc.
Decision Date2016-12-28
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed Stryker External Fixation Devices is a medical device manufactured by Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2016-12-28 under approval number K163028. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline ReNewal Reprocessed Stryker External Fixation Devices?

Medline ReNewal Reprocessed Stryker External Fixation Devices is a medical device that received FDA 510(k) clearance on 2016-12-28. It is manufactured by Surgical Instrument Service and Savings, Inc.. The 510(k) number is K163028.

When was Medline ReNewal Reprocessed Stryker External Fixation Devices approved by the FDA?

Medline ReNewal Reprocessed Stryker External Fixation Devices received FDA 510(k) clearance on 2016-12-28, under approval number K163028.

What company makes Medline ReNewal Reprocessed Stryker External Fixation Devices?

Medline ReNewal Reprocessed Stryker External Fixation Devices is manufactured by Surgical Instrument Service and Savings, Inc..

What is the FDA product code for Medline ReNewal Reprocessed Stryker External Fixation Devices?

The FDA product code for Medline ReNewal Reprocessed Stryker External Fixation Devices is JEC.

Related Clinical Trials

NCT05587010 Comparison of Gait in Different Support Conditions for Foot Drop COMPLETED NCT07561567 Feasibility and Effectiveness of Respiratory Movement Management in Lung Cancer Receiving Stereotactic Radiotherapy Using a Novel Positional Fixation Device RECRUITING NCT04823663 BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES) RECRUITING NCT07233876 DuoCor 2 DOMINATE Study NOT_YET_RECRUITING NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07508774 Simulation and Feasibility Study of Drone-Delivered AED for Out-of-Hospital Cardiac Arrest NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 39993988 [Analysis of Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Surgical Instrument Service and Savings, Inc.

K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider K160740Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology K171911Medline ReNewal Reprocessed Synthes External Fixation Systems K172608Medline ReNewal Reprocessed Stryker SERF AS Energy Probes K161358Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds K171324Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

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Related Devices (Code: JEC)

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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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