Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Synthes Graphic Case & Tray System

K-Number: K241927 · 2025-03-28

ApplicantSynthes GmbH
Decision Date2025-03-28
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Synthes Graphic Case & Tray System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes GmbH. It received FDA 510(k) clearance on 2025-03-28 under 510(k) number K241927. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synthes Graphic Case & Tray System?

Synthes Graphic Case & Tray System is a medical device that received FDA 510(k) clearance on 2025-03-28. The listed applicant is Synthes GmbH. The 510(k) number is K241927.

When did Synthes Graphic Case & Tray System receive FDA 510(k) clearance?

Synthes Graphic Case & Tray System received FDA 510(k) clearance on 2025-03-28, under 510(k) number K241927.

Who is the listed applicant for Synthes Graphic Case & Tray System?

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

What is the FDA product code for Synthes Graphic Case & Tray System?

The FDA product code for Synthes Graphic Case & Tray System is KCT.

Other records listing Synthes GmbH 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.

K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemK260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemK254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemK243715Synthes Patient Specific ImplantsK233994VOLT™ Proximal Humerus 3.5 Plating SystemK233967DePuy Synthes MatrixSTERNUM Fixation System

View all 7 devices →

Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., 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.

↑