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FDA 510(k)

DEPUY SYNTHES MAXFRAME AUTOSTRUT System

K-Number: K231922 · 2023-07-26

ApplicantDePuy Synthes
Decision Date2023-07-26
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY SYNTHES MAXFRAME AUTOSTRUT System is a medical device manufactured by DePuy Synthes. It received FDA 510(k) clearance on 2023-07-26 under approval number K231922. 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 AUTOSTRUT System?

DEPUY SYNTHES MAXFRAME AUTOSTRUT System is a medical device that received FDA 510(k) clearance on 2023-07-26. It is manufactured by DePuy Synthes. The 510(k) number is K231922.

When was DEPUY SYNTHES MAXFRAME AUTOSTRUT System approved by the FDA?

DEPUY SYNTHES MAXFRAME AUTOSTRUT System received FDA 510(k) clearance on 2023-07-26, under approval number K231922.

What company makes DEPUY SYNTHES MAXFRAME AUTOSTRUT System?

DEPUY SYNTHES MAXFRAME AUTOSTRUT System is manufactured by DePuy Synthes.

What is the FDA product code for DEPUY SYNTHES MAXFRAME AUTOSTRUT System?

The FDA product code for DEPUY SYNTHES MAXFRAME AUTOSTRUT System is KTT.

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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

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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