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FDA 510(k)

Hoffmann LRF (Limb Reconstruction Frame) System

K-Number: K153377 · 2016-04-11

ApplicantStryker GmbH
Decision Date2016-04-11
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hoffmann LRF (Limb Reconstruction Frame) System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2016-04-11 under approval number K153377. 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 (Limb Reconstruction Frame) System?

Hoffmann LRF (Limb Reconstruction Frame) System is a medical device that received FDA 510(k) clearance on 2016-04-11. It is manufactured by Stryker GmbH. The 510(k) number is K153377.

When was Hoffmann LRF (Limb Reconstruction Frame) System approved by the FDA?

Hoffmann LRF (Limb Reconstruction Frame) System received FDA 510(k) clearance on 2016-04-11, under approval number K153377.

What company makes Hoffmann LRF (Limb Reconstruction Frame) System?

Hoffmann LRF (Limb Reconstruction Frame) System is manufactured by Stryker GmbH.

What is the FDA product code for Hoffmann LRF (Limb Reconstruction Frame) System?

The FDA product code for Hoffmann LRF (Limb Reconstruction Frame) System is KTT.

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Related PubMed Literature

PMID: 40223422 Cell-Free Biomimetic Tracheal Graft via Hybrid 3D Printing for Enhanced Tracheal Reconstruction. Advanced healthcare materials (2025)

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 K172350AxSOS 3 Ti K173135VariAx 2 System

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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 K151881X-Fix Line AdditionsVilex IN Tennessee, Inc. K151580D.N.E. External Fixation SystemDne, LLC

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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