FDA 510(k)

AutoStrut

K-Number: K191241 · 2019-08-14

Decision Date2019-08-14

Product CodeKTT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AutoStrut is the device name listed in this FDA 510(k) record. The listed applicant is Orthospin. It received FDA 510(k) clearance on 2019-08-14 under 510(k) number K191241. 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 AutoStrut?

AutoStrut is a medical device that received FDA 510(k) clearance on 2019-08-14. The listed applicant is Orthospin. The 510(k) number is K191241.

When did AutoStrut receive FDA 510(k) clearance?

AutoStrut received FDA 510(k) clearance on 2019-08-14, under 510(k) number K191241.

Who is the listed applicant for AutoStrut?

The FDA 510(k) record lists Orthospin as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AutoStrut?

The FDA product code for AutoStrut is KTT.

Other records listing Orthospin 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.

K202810AutoStrut G2

Related Devices (Code: KTT)

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC K260900DYNEX® External Fixation SystemsVilex, LLC K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean Global K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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.