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FDA 510(k)

Sequel External Fixation Device

K-Number: K202833 · 2021-01-19

ApplicantSequel Medical, Inc.
Decision Date2021-01-19
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sequel External Fixation Device is a medical device manufactured by Sequel Medical, Inc.. It received FDA 510(k) clearance on 2021-01-19 under approval number K202833. 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 Sequel External Fixation Device?

Sequel External Fixation Device is a medical device that received FDA 510(k) clearance on 2021-01-19. It is manufactured by Sequel Medical, Inc.. The 510(k) number is K202833.

When was Sequel External Fixation Device approved by the FDA?

Sequel External Fixation Device received FDA 510(k) clearance on 2021-01-19, under approval number K202833.

What company makes Sequel External Fixation Device?

Sequel External Fixation Device is manufactured by Sequel Medical, Inc..

What is the FDA product code for Sequel External Fixation Device?

The FDA product code for Sequel External Fixation Device is KTT.

Related Clinical Trials

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41613162 Evaluating Translational AI: A Two-Way Moving Target Problem. NEJM AI (2025) PMID: 40920948 [The internal condom: overview, practical aspects and analysis of the barriers to its use]. Medecine sciences : M/S (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

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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