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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 the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2023-07-26 under 510(k) 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. The listed applicant is DePuy Synthes. The 510(k) number is K231922.

When did DEPUY SYNTHES MAXFRAME AUTOSTRUT System receive FDA 510(k) clearance?

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

Who is the listed applicant for DEPUY SYNTHES MAXFRAME AUTOSTRUT System?

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

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

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

Other records listing DePuy Synthes 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.

K233696DePuy Synthes Retrograde Femoral Nail Advanced SystemK233256Robotic Integration InstrumentsK233255CROSSNAV Navigation Enabled InstrumentsK233254TELIGEN System Navigation Ready InstrumentsK233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating SystemK221809DePuy Synthes 3.5mm Intrapelvic Acetabular System

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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