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FDA 510(k)

Medline ReNewal Reprocessed Synthes External Fixation Systems

K-Number: K171911 · 2017-11-09

ApplicantSurgical Instrument Service and Savings, Inc.
Decision Date2017-11-09
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed Synthes External Fixation Systems is a medical device manufactured by Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2017-11-09 under approval number K171911. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline ReNewal Reprocessed Synthes External Fixation Systems?

Medline ReNewal Reprocessed Synthes External Fixation Systems is a medical device that received FDA 510(k) clearance on 2017-11-09. It is manufactured by Surgical Instrument Service and Savings, Inc.. The 510(k) number is K171911.

When was Medline ReNewal Reprocessed Synthes External Fixation Systems approved by the FDA?

Medline ReNewal Reprocessed Synthes External Fixation Systems received FDA 510(k) clearance on 2017-11-09, under approval number K171911.

What company makes Medline ReNewal Reprocessed Synthes External Fixation Systems?

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

What is the FDA product code for Medline ReNewal Reprocessed Synthes External Fixation Systems?

The FDA product code for Medline ReNewal Reprocessed Synthes External Fixation Systems is KTT.

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Related PubMed Literature

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Other Devices by Surgical Instrument Service and Savings, Inc.

K163028Medline ReNewal Reprocessed Stryker External Fixation Devices K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider K160740Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology 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: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.

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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