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FDA 510(k)

DePuy Synthes MAXFRAME Multi-Axial Correction System

K-Number: K161417 · 2016-11-10

ApplicantSynthes USA, LLC
Decision Date2016-11-10
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes MAXFRAME Multi-Axial Correction System is a medical device manufactured by Synthes USA, LLC. It received FDA 510(k) clearance on 2016-11-10 under approval number K161417. 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 DePuy Synthes MAXFRAME Multi-Axial Correction System?

DePuy Synthes MAXFRAME Multi-Axial Correction System is a medical device that received FDA 510(k) clearance on 2016-11-10. It is manufactured by Synthes USA, LLC. The 510(k) number is K161417.

When was DePuy Synthes MAXFRAME Multi-Axial Correction System approved by the FDA?

DePuy Synthes MAXFRAME Multi-Axial Correction System received FDA 510(k) clearance on 2016-11-10, under approval number K161417.

What company makes DePuy Synthes MAXFRAME Multi-Axial Correction System?

DePuy Synthes MAXFRAME Multi-Axial Correction System is manufactured by Synthes USA, LLC.

What is the FDA product code for DePuy Synthes MAXFRAME Multi-Axial Correction System?

The FDA product code for DePuy Synthes MAXFRAME Multi-Axial Correction System is KTT.

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Related PubMed Literature

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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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