FDA 510(k)

Hoffmann LRF System

K-Number: K182968 · 2019-01-25

Decision Date2019-01-25

Product CodeKTT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Hoffmann LRF System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2019-01-25 under approval number K182968. 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 Hoffmann LRF System?

Hoffmann LRF System is a medical device that received FDA 510(k) clearance on 2019-01-25. It is manufactured by Stryker GmbH. The 510(k) number is K182968.

When was Hoffmann LRF System approved by the FDA?

Hoffmann LRF System received FDA 510(k) clearance on 2019-01-25, under approval number K182968.

What company makes Hoffmann LRF System?

Hoffmann LRF System is manufactured by Stryker GmbH.

What is the FDA product code for Hoffmann LRF System?

The FDA product code for Hoffmann LRF System is KTT.

Other Devices by Stryker GmbH

K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) K161753Hoffman LRF System K160813EasyStep K153379AxSOS 3Ti K153377Hoffmann LRF (Limb Reconstruction Frame) System K172350AxSOS 3 Ti

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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

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