FDA 510(k)

Reprocessed Stryker External Fixation Devices

K-Number: K153415 · 2016-01-13

ApplicantStryker Sustainability Solutions

Decision Date2016-01-13

Product CodeKTT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Reprocessed Stryker External Fixation Devices is a medical device manufactured by Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2016-01-13 under approval number K153415. 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 Reprocessed Stryker External Fixation Devices?

Reprocessed Stryker External Fixation Devices is a medical device that received FDA 510(k) clearance on 2016-01-13. It is manufactured by Stryker Sustainability Solutions. The 510(k) number is K153415.

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

Reprocessed Stryker External Fixation Devices received FDA 510(k) clearance on 2016-01-13, under approval number K153415.

What company makes Reprocessed Stryker External Fixation Devices?

Reprocessed Stryker External Fixation Devices is manufactured by Stryker Sustainability Solutions.

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

The FDA product code for Reprocessed Stryker 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)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.