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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 the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2017-11-09 under 510(k) 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. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K171911.

When did Medline ReNewal Reprocessed Synthes External Fixation Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for Medline ReNewal Reprocessed Synthes External Fixation Systems?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Surgical Instrument Service and Savings, Inc. as applicant

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.

K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerK252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CatheterK250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic CatheterK250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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