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FDA 510(k)

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices

K-Number: K180580 · 2018-07-27

ApplicantSurgical Instrument Service and Savings, Inc.
Decision Date2018-07-27
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices is a medical device manufactured by Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2018-07-27 under approval number K180580. 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 Smith & Nephew Jet-X External Fixation Devices?

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices is a medical device that received FDA 510(k) clearance on 2018-07-27. It is manufactured by Surgical Instrument Service and Savings, Inc.. The 510(k) number is K180580.

When was Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices approved by the FDA?

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices received FDA 510(k) clearance on 2018-07-27, under approval number K180580.

What company makes Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices?

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices is manufactured by Surgical Instrument Service and Savings, Inc..

What is the FDA product code for Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices?

The FDA product code for Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices is KTT.

Related Clinical Trials

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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.

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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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